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FDA industry systems - Accounts management

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FDA Industry Systems

SYSTEM

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HELP DESK

STATUS

LOGIN

GETTING STARTED

Existing account holders, enter your account ID & password.
Account ID:

To make submissions to FDA (e.g., Food Facility Registration, Prior Notice, etc.) you must
first create an account. Select "Create New Account" below.

gns21746

If you already have an account, enter your account ID and password.

Password:

Under 18 U.S.C. 1001, anyone who makes a
materially false, fictitious, or fraudulent statement to
the U.S. Government is subject to criminal penalties.
I Understand  

login

WARNING: You are accessing a U.S. Government information system. The system usage may be
monitored, recorded, and subject to audit. Unauthorized use of the system is prohibited and subject
to criminal and civil penalties. Use of the system indicates consent to monitoring and recording, and
Anyone using this system expressly consents to such monitoring and is advised that if such
monitoring reveals possible criminal activity, system personnel may provide the evidence of such
monitoring to law enforcement officials.
Is your computer secure? Before using FDA Industry Systems (FIS), FDA strongly encourages all
users to have current antivirus and antispyware software installed on your computer to help ensure
the privacy of the information being entered.

Forgot your password?

FDA retains contractors to assist the agency in maintaining its databases. If you get a call from
someone asking about your facility and you are concerned about whether the call is legitimate, get
the name and company of the caller, as well as a phone number, and contact FDA FURLS
Helpdesk at 1-800-216-7331 to confirm that the caller is acting on behalf of FDA.

NEW USER

Create New Account

See Instructions

See Tutorials

Help Desk

FDA Industry Systems Home
Food Facility Registration

Prior Notice System Interface (PNSI)

Browser Requirements

FAQ

Acidified and Low-Acid Canned Food

Help Desk
Certificate Application Process

Privacy

http://access.dev.fda.gov/oaa/logonFlow.htm;jsessionid=0hHhQBHYvL3Fvkp5m67m88jvgT2bZCgfJF0LDWpXpMBljFGl6D6y!-1286128766?execution=e1s1[8/31/2012 2:53:44 PM]

Accessibility

FDA industry systems - Accounts management

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Account Management
Account Management
Edit Account Profile

WELCOME  You are logged in as gns21746

Change My Password

Welcome to the FDA Industry Systems.

Update System Access

You are logged in to your account for company gnsi

Create a Subaccount
Deactivate a Subaccount
Reactivate a Subaccount

You may choose an option on the left to manage your account or select an FDA system below.
To obtain access to available FDA systems, choose the Update System Access option to add the
FDA system to your account.

FDA UNIFIED REGISTRATION LISTING SYSTEMS
Food Facility Registration

Device Registration & Listing

Shell Egg Registration

Drug Facility Registration

Acidified/Low Acid Canned Foods

Certificate Application Process

CDRH Export Certificate Application & Tracking System

OTHER FDA SYSTEMS
Prior Notice of Imported Food

FDA Industry Systems Home
Food Facility Registration

Prior Notice System Interface (PNSI)

http://access.dev.fda.gov/oaa/logonFlow.htm?execution=e1s2[8/31/2012 2:54:05 PM]

Browser Requirements

FAQ

Acidified and Low-Acid Canned Food

Help Desk
Certificate Application Process

Privacy

Accessibility

logout

CDRH Export Certificate Application and Tracking System Main Menu

Form Approval: OMB No.0910-0498

Expiration date:3/31/2015
See OMB Statement at end of form

An Agency may not conduct or sponsor, and a person is not required to
respond to a collection of information unless it displays a currently valid
OMB control number.

Please Note:
The system will automatically time out if there is no activity for 30
minutes and you will need to re-do your work from the beginning.

http://access.dev.fda.gov/...!-1286128766!1346439160232rO0ABXQACGduczIxNzQ2134643927973400&uid=rO0ABXQACGduczIxNzQ2[8/31/2012 2:54:49 PM]

Enter New Application

Please select the certificate type you are applying for. If you are unsure as to which one to select,
please click on the "ICON" for a description of each certificate type.

* - These fields are required
Certificate Type :
Certificateto to
Foreign
Government
Certificate
Foreign
Government
(CFG)(CFG)

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s1[8/31/2012 2:55:24 PM]

Enter New Application

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s1[8/31/2012 2:55:24 PM]

Enter New Application Step 1

If the information below is incorrect, you will need to update your account before proceeding
any further . Click on here to navigate to the Online Account Administration to make the
necessary updates.

      * - These fields are required

*Salutation
Mr.
Mr.

*First Name

Vijay

Middle Initial

*Last Name

Maringanti

*Title

sw

*Firm
gnsi

*Country / Area
UNITEDSTATES
STATES
UNITED

*Address Line 1

11820 Parklawn DR

Address Line 2

300

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s2[8/31/2012 2:57:53 PM]

Enter New Application Step 1

*Zip Code (Postal Code)

20852

* City

Rockville

*State / Province / Territory

Maryland

Numbers only. No spaces, dashes or parentheses. Country
Code is not required for U.S. phone numbers.

          Country
Code

Area / City
*Phone Number Extension
Code

          (e.g.001)

(e.g.101)

*Phone
Number

          Code

Area / City
Fax Number
Code

          (e.g.001)

(e.g.101)

301
Country

(e.g.5551111)

(e.g.1111)

4656565

(e.g.5551111)

Fax

Number

*Firm Tax ID Code

12

  -   1211111

*Email Address

[email protected]

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s2[8/31/2012 2:57:53 PM]

Address Validation

STEP1 ADDRESS VALIDATION

This address has been verified; however minor modifications were made to the information
you entered. Please indicate whether you wish to accept the modifications we made, or Click
on FURLSHome to navigate to the Online Account Administration to make the necessary
updates.

YOUR ADDRESS
REQUESTOR FIRM NAME: gnsi
REQUESTOR FIRST NAME: Vijay
REQUESTOR LAST NAME: Maringanti
STREET ADDRESS, Line 1:  11820 Parklawn DR
STREET ADDRESS, Line 2:  300
CITY:  Rockville
STATE:  Maryland
ZIP/POSTAL CODE:  20852
COUNTRY:  UNITED STATES

VALIDATED ADDRESS
REQUESTOR FIRM NAME: gnsi
REQUESTOR FIRST NAME: Vijay
REQUESTOR LAST NAME: Maringanti
STREET ADDRESS, Line 1:  11820 Parklawn Dr Ste 300
STREET ADDRESS, Line 2: 
CITY:  Rockville
STATE:  Maryland
ZIP/POSTAL CODE:  20852-2529
COUNTRY:  UNITED STATES

Accept validated address and continue

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s3[8/31/2012 2:59:12 PM]

Address Validation

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s3[8/31/2012 2:59:12 PM]

Enter New Application Step 2

The FDA requires that all facilities manufacturing medical devices must be registered in the FDA
Device Registration and Listing Facility(DRLM) system. Once a manufacturer is registered in the
DRLM, the FDA provides an Owner Operator Number to the requesting firm. The FDA also
assigns a Registration number for every manufacturer registered in DRLM.If you have not
registered your manufacturer in DRLM, click on here  to navigate to DRLM and register your
manufacturer. Otherwise, please enter the Registration Number or the Owner Operator Number.

* - These fields are required
*Registration Number :
OR
*Owner Operator Number : 10033918

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s4[8/31/2012 2:59:37 PM]

Enter New Application Step 2

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s4[8/31/2012 2:59:37 PM]

Enter New Application Step 2

Please select a manufacturer(s) and click add.
NOTE: Only a manufacturer in an "Active" or "Active Pending Registration Number" status in DRLM
can be selected.

Registration
Number

Firm

✔

Status

GNSI - Class I Exempt
Only With Inspection

Active

GNSI - Class I Exempt
Only With No Inspection

Active

Address (P.O. Box not acceptable)

311 W Side Dr Apt 301 ,
Gaithersburg , Maryland
UNITED STATES , 20878
11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s5[8/31/2012 2:59:57 PM]

Enter New Application Step 2

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s5[8/31/2012 2:59:57 PM]

Enter New Application Step 2

The following manufacturer(s) has been added to the certificate request.
Firm

Registration
Number

GNSI - Class I Exempt
Only With Inspection
Do you want to add another manufacturer?

Status

Active

Yes

Address (P.O. Box not acceptable)

311 W Side Dr Apt 301 ,
Gaithersburg, Maryland
UNITED STATES , 20878

No

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s6[8/31/2012 3:00:14 PM]

Enter New Application Step 2

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s6[8/31/2012 3:00:14 PM]

Enter New Application Step 2

The FDA requires that all facilities manufacturing medical devices must be registered in the FDA
Device Registration and Listing Facility(DRLM) system. Once a manufacturer is registered in the
DRLM, the FDA provides an Owner Operator Number to the requesting firm. The FDA also
assigns a Registration number for every manufacturer registered in DRLM.If you have not
registered your manufacturer in DRLM, click on here  to navigate to DRLM and register your
manufacturer. Otherwise, please enter the Registration Number or the Owner Operator Number.

* - These fields are required
*Registration Number : 786898
OR
*Owner Operator Number :

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s7[8/31/2012 3:01:00 PM]

Enter New Application Step 2

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s7[8/31/2012 3:01:00 PM]

Enter New Application Step 2

Please select a manufacturer(s) and click add.
NOTE: Only a manufacturer in an "Active" or "Active Pending Registration Number" status in DRLM
can be selected.

Registration
Number

Firm

✔

RICK'S MEDICAL
DEVICE FIRM(510k)

786898

Status

Active

Address (P.O. Box not acceptable)

11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s8[8/31/2012 3:01:17 PM]

Enter New Application Step 2

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s8[8/31/2012 3:01:17 PM]

Enter New Application Step 2

The following manufacturer(s) has been added to the certificate request.
Firm

Registration
Number

RICK'S MEDICAL DEVICE
786898
FIRM(510k)
Do you want to add another manufacturer?

Status

Active

Yes

Address (P.O. Box not acceptable)

11820 Parklawn Dr Ste 300 ,
Rockville, Maryland
UNITED STATES , 20852

No

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s9[8/31/2012 3:01:30 PM]

Enter New Application Step 2

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s9[8/31/2012 3:01:30 PM]

Enter New Application Step 2

     * - These fields are required

Firm Name
GNSI - Class I Exempt Only With Inspection

Registration Number

Address Line 1

311 W Side Dr Apt 301

Address Line 2

City

Gaithersburg

State / Province / Territory

Maryland

*Country / Area

UNITED STATES

Zip Code (Postal code)

20878

License Number (if applicable)

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s11[8/31/2012 3:01:58 PM]

Enter New Application Step 2

Date of Last FDA inspection (MM/DD/YYYY)

03/01/2011

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s11[8/31/2012 3:01:58 PM]

Enter New Application Step 2

The following manufacturer(s) has been added to the certificate request.
You may optionally enter the Date of Last FDA Inspection by selecting the manufacturer and clicking on "Edit".
You can add an additional manufacturer by clicking on "Add".
You can remove an existing manufacturer by selecting a manufacturer and clicking on "Remove".

Registration
Number

Firm

GNSI - Class I
Exempt Only
With Inspection
RICK'S
MEDICAL
DEVICE
FIRM(510k)

License
number(if
applicable)

Date of
Last FDA
Inspection

03/01/2011

Address (P.O. Box not
acceptable)

311 W Side Dr Apt 301,
Gaithersburg, Maryland
UNITED STATES , 20878
11820 Parklawn Dr Ste 300,
Rockville, Maryland
UNITED STATES , 20852

786898

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s12[8/31/2012 3:02:11 PM]

Enter New Application Step 2

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s12[8/31/2012 3:02:11 PM]

Enter New Application Step 3

The FDA requires that all facilities manufacturing medical devices must be registered in the FDA
Device Registration and Listing Facility(DRLM) system. Once a distributor is registered in the
DRLM, the FDA provides an Owner Operator Number to the requesting firm. The FDA also
assigns a Registration number for every distributor registered in DRLM.If you have not
registered your distributor in DRLM, click on here  to navigate to DRLM and register your
distributor. Otherwise, please enter the Registration Number or the Owner Operator Number.

* - These fields are required
*Registration Number : 786898
OR
*Owner Operator Number :

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s15[8/31/2012 3:02:41 PM]

Enter New Application Step 3

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s15[8/31/2012 3:02:41 PM]

Enter New Application Step 3

Please select a distributor(s) and click add.
NOTE: Only a domestic distributor in an "Active" or "Active Pending Registration Number" status in DRLM can
be selected.

Registration
Number

Firm

✔

RICK'S MEDICAL
DEVICE FIRM(510k)

786898

Status

Active

Address (P.O. Box not acceptable)

11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s16[8/31/2012 3:02:54 PM]

Enter New Application Step 3

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s16[8/31/2012 3:02:54 PM]

Enter New Application Step 3

The following distributor(s) has been added to the certificate request.
Firm

RICK'S MEDICAL
DEVICE FIRM(510k)

Registration
Number

Status

786898

Do you want to add more distributor's?

Active

Yes

Address (P.O. Box not acceptable)

11820 Parklawn Dr Ste 300 , ,
Rockville,
Maryland,
UNITED STATES , 20852

No

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s17[8/31/2012 3:03:13 PM]

Enter New Application Step 3

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s17[8/31/2012 3:03:13 PM]

Enter New Application Step 3

The following distributor(s) has been added to the certificate request.
Select

Registration
Number

Firm

RICK'S MEDICAL
DEVICE FIRM(510k)

Address (P.O. Box not acceptable)

11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

786898

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s18[8/31/2012 3:09:05 PM]

Enter New Application Step 3

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s18[8/31/2012 3:09:05 PM]

Enter New Application Step 4

Warning: You may list Class III products only if the manufacturing facility has been inspected by the FDA.
Failure to comply will prompt the FDA to immediately reject the certificate request.
*Will you be listing any refurbished or remanufactured products in this application?
*Are you the original manufacturer of this product(s)?

Yes

Yes

No

Please be advised that any refurbished or remanufactured product cannot appear on the
certificate unless you are the original manufacturer.

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s19[8/31/2012 3:09:24 PM]

No

Enter New Application Step 4

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s19[8/31/2012 3:09:24 PM]

Enter New Application Step 4

In this section you will be able to retrieve all products associated to a facility registered in DRLM.
Please select a facility and click on "Add/Remove Product"
NOTE: You must select at least one product for each facility listed below in order to continue.

Select
Manufacturer
Product Details
GNSI - Class I Exempt
Only With Inspection
RICK'S MEDICAL
DEVICE FIRM(510k)
786898
Select

Distributor
RICK'S MEDICAL
DEVICE FIRM(510k)
786898

Product Details

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s20[8/31/2012 3:09:44 PM]

Enter New Application Step 4

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s20[8/31/2012 3:09:44 PM]

Enter New Application Step 4

Please select the product(s) for this facility.You may optionally enter the Trade Name and or
Proper Name for each product selected.
If you wish to have the Proper Name printed on the certificate, you will need to enter the
Proper Name for each product.
NOTE: Only the Proper Name can be printed on the certificate.

Marketing
Status
✔

Product
Code

Exempt

JCF

Exempt

GIF

Product Name

LYMPHOCYTE
SEPARATION
MEDIUM
DILUENT, BLOOD
CELL

Trade Name

tn1

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s21[8/31/2012 3:09:56 PM]

Proper Name

pn1

Enter New Application Step 4

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s21[8/31/2012 3:09:56 PM]

Enter New Application Step 4

Please select the product(s) for this facility.You may optionally enter the Trade Name and or
Proper Name for each product selected.
If you wish to have the Proper Name printed on the certificate, you will need to enter the
Proper Name for each product.
NOTE: Only the Proper Name can be printed on the certificate.

Marketing
Status
✔

Product
Code

Exempt

JCF

Exempt

GIF

Product Name

LYMPHOCYTE
SEPARATION
MEDIUM
DILUENT, BLOOD
CELL

Trade Name

tn1

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s21[8/31/2012 3:10:13 PM]

Proper Name

pn1

Enter New Application Step 4

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s21[8/31/2012 3:10:13 PM]

Enter New Application Step 4

In this section you will be able to retrieve all products associated to a facility registered in DRLM.
Please select a facility and click on "Add/Remove Product"
NOTE: You must select at least one product for each facility listed below in order to continue.

Select
Manufacturer
Product Details
Proper Name
Marketing Status
GNSI - Class I Exempt Trade Name
Only With Inspection
tn1
pn1
Exempt
RICK'S MEDICAL
DEVICE FIRM(510k)
786898
Select

Distributor
RICK'S MEDICAL
DEVICE FIRM(510k)
786898

Product Details

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s22[8/31/2012 3:10:29 PM]

Enter New Application Step 4

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s22[8/31/2012 3:10:29 PM]

Enter New Application Step 4

Please select the product(s) for this facility.You may optionally enter the Trade Name and or
Proper Name for each product selected.
If you wish to have the Proper Name printed on the certificate, you will need to enter the
Proper Name for each product.
NOTE: Only the Proper Name can be printed on the certificate.

Marketing
Status

Product
Code

DPS
DQK
✔

K991735
DXH
LOS
KWP

✔

K974749

KWQ

MNH

DIO

DKZ
K992748
DPK
LCM

Product Name

ELECTROCARDIOGR
APH
COMPUTER,
DIAGNOSTIC,
PROGRAMMABLE
TRANSMITTERS AND
RECEIVERS,
ELECTROCARDIOGR
APH, TELEPHONE
System, ecg analysis
APPLIANCE,
FIXATION, SPINAL
INTERLAMINAL
APPLIANCE,
FIXATION, SPINAL
INTERVERTEBRAL
BODY
Orthosis,
spondylolisthesis
spinal fixation
ENZYME
IMMUNOASSAY,
COCAINE AND
COCAINE
METABOLITES
ENZYME
IMMUNOASSAY,
AMPHETAMINE
LIQUID
CHROMATOGRAPHY,
MORPHINE
Enzyme immunoassay,
phencyclidine
ENZYME

Trade Name

Proper Name

Trade Name2

Proper Name2

Trade Name3

Proper Name3

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Enter New Application Step 4

LDJ

IMMUNOASSAY,
CANNABINOIDS

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s23[8/31/2012 3:11:17 PM]

Enter New Application Step 4

In this section you will be able to retrieve all products associated to a facility registered in DRLM.
Please select a facility and click on "Add/Remove Product"
NOTE: You must select at least one product for each facility listed below in order to continue.

Select
Manufacturer
Product Details
Proper Name
Marketing Status
GNSI - Class I Exempt Trade Name
Only With Inspection
tn1
pn1
Exempt
RICK'S MEDICAL
DEVICE FIRM(510k)
786898
Select

Trade Name
Trade Name2
Trade Name3

Proper Name
Proper Name2
Proper Name3

Distributor
RICK'S MEDICAL
DEVICE FIRM(510k)
786898

Product Details

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s24[8/31/2012 3:12:19 PM]

Marketing Status
K991735
K974749

Enter New Application Step 4

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s24[8/31/2012 3:12:19 PM]

Enter New Application Step 5

If any product listed below has ever been recalled, please place a checkmark next to the product and enter
the FDA Issued Recall Number.
Once completed, click on "Continue"

Recalled
✔

Marketing
Status

Firm

GNSI - Class I Exempt Only
Exempt
With Inspection

Product
Code

JCF

Product Name

LYMPHOCYTE SEPARATION MEDIUM
Close-out Date

FDA Issued Recall Number : Z-  1039

  -   05
DPS

RICK'S MEDICAL DEVICE
FIRM(510k)

DQK
K991735
DXH
LOS

FDA Issued Recall Number : Z- 

 - 
KWP

RICK'S MEDICAL DEVICE
FIRM(510k)

K974749

KWQ
MNH

FDA Issued Recall Number : Z- 

 - 

(MM/DD/YYYY) :
ELECTROCARDIOGRAPH
COMPUTER, DIAGNOSTIC,
PROGRAMMABLE
TRANSMITTERS AND RECEIVERS,
ELECTROCARDIOGRAPH, TELEPHONE
System, ecg analysis
Close-out Date
(MM/DD/YYYY) :
APPLIANCE, FIXATION, SPINAL
INTERLAMINAL
APPLIANCE, FIXATION, SPINAL
INTERVERTEBRAL BODY
Orthosis, spondylolisthesis spinal fixation
Close-out Date
(MM/DD/YYYY) :

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Enter New Application Step 5

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s25[8/31/2012 3:12:50 PM]

Enter New Application Step 5

Our records indicate that the product(s) listed below does not have a recall close-out date. If available, please
upload the official Close-Out Letter for each recalled product. Failure to do so may cause a delay in the
certificate processing.
NOTE: The Close-Out Letter attachment cannot exceed 50MB (Megabytes).
The total file size of all Close-Out Letter attachments cannot exceed 50MB (Megabytes).
The accepted file formats include pdf, bmp, jpeg, gif, png, tiff, doc, and docx.

Product
Code

Firm

GNSI Class I
Exempt
Only With
Inspection

Product Name

LYMPHOCYTE
SEPARATION
MEDIUM

JCF

FDA
Issued
Recall
Number

Z-103905

Close-out-Letter

no file selected

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Enter New Application Step 5

http://access.dev.fda.gov/cecats/enterNewApplication-flow.htm?execution=e1s26[8/31/2012 3:13:01 PM]

Enter New Application Step 6

*NAME OF COUNTRY or COUNTRIES
AFGHANISTAN
AFGHANISTAN
ALAND ISLANDS
ALAND
ALBANIA ISLANDS
ALGERIA
ALBANIA
AMERICAN SAMOA
ALGERIA
ANDORRA
ANGOLA
AMERICAN
SAMOA
ANGUILLA
ANDORRA

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AFGHANISTAN
AFGHANISTAN
ALAND ISLANDS

ALAND ISLANDS

Enter New Application Step 6

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Enter New Application Step 7

*Please select primary facility :

GNSI
I Exempt
OnlyOnly
WithWith
Inspection
- Manufacturer
GNSI- Class
- Class
I Exempt
Inspection
- Manufacturer

*Do you want to display the owner operator address for the primary facility selected on the
certificate ?
Yes
No

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Enter New Application Step 7

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Enter New Application Step 7

Select the facilities and Header / Sub header names that you wish to appear on the certificate :
Select Manufacturer
GNSI - Class I Exempt
✔
Only With Inspection
RICK'S
MEDICAL
✔
DEVICE FIRM(510k)

Header Name

SubHeader Name

Name
NameofofManufacturer/Distributor
Manufacturer/Distributor

Manufacturing
Facility
Manufacturing
Facility

Name
Operator
NameofofOwner
Owner
Operator

Formerly
As As
FormerlyKnown
Known

Formerly Known As : Former Firm Name goes here
Select Distributor
RICK'S MEDICAL
✔
DEVICE FIRM(510k)

Header Name
Name
NameofofDistributor
Distributor

SubHeader Name
Manufactured
ForFor
Manufactured

Manufactured For : Manufacturer firm name goes here.

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Enter New Application Step 7

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Enter New Application Step 7

NOTE: If you have not entered all of the Proper Names for each product in section 4, please go back and
enter the information, or you will not be able to select "Use the existing product listing (from section 4) to
appear on the certificate?"
Use the existing product listing (from section 4) to appear on the certificate?
OR
Upload your product accessories?

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Enter New Application Step 7

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Enter New Application Step 7

This section allows you to associate each product or product listing to one or more facilities that have been
identified to be printed on the certificate. The associations you create will impact the printout of your
certificate.
Select one or multiple products from each page. Then select one or more facilities. When you are finished,
click on "Group". Continue grouping the remaining products until all products from the first page has been
grouped. Click on the "Next" hyperlink to continue to the next set of products (if available).
NOTE: You must associate each product to at least one facility. If there are multiple pages of products, you
must associate the products for each page before continuing to the next page of products.
Refer to the online help for more detailed instructions on product groupings and an example of a certificate
printout.

Owner
Operator/Manufacturer(s)/Distributor(s)

Products

pn1
Proper Name2

Proper Name3

Manufacturer(s)
GNSI - Class I Exempt Only With
Inspection
RICK'S MEDICAL DEVICE
FIRM(510k)-786898
Distributor(s)
RICK'S MEDICAL DEVICE
FIRM(510k)-786898

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Enter New Application Step 7

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Enter New Application Step 7

NOTE: If you have not entered all of the Proper Names for each product in section 4, please go back and
enter the information, or you will not be able to select "Use the existing product listing (from section 4) to
appear on the certificate?"
Use the existing product listing (from section 4) to appear on the certificate?
OR
Upload your product accessories?

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Enter New Application Step 7

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Enter New Application Step 7

The maximum allowed file size is 50 MB (Megabytes).The accepted file types are Microsoft 2007 or 2010 Excel
Spreadsheets (.xls or .xlsx). Click here to download the product template file.
Select the file to upload:  
no file selected

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Enter New Application Step 7

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Enter New Application Step 7

This section allows you to associate each product or product listing to one or more facilities that have been
identified to be printed on the certificate. The associations you create will impact the printout of your
certificate.
Select one or multiple products from each page. Then select one or more facilities. When you are finished,
click on "Group". Continue grouping the remaining products until all products from the first page has been
grouped. Click on the "Next" hyperlink to continue to the next set of products (if available).
NOTE: You must associate each product to at least one facility. If there are multiple pages of products, you
must associate the products for each page before continuing to the next page of products.
Refer to the online help for more detailed instructions on product groupings and an example of a certificate
printout.

Products

Extracting forceps , American Pattern , Fig A 151 S
Pillers , Endo noteched Locking
Needle holders, CRILE-WOOD , 15cm
Needle holders, DERF , 12.5cm
Needle holders, MAYO-HEGAR , 16cm
Rubberdam punch , IVORY
Rubberdam punch , AINSWORTH
Rubberdam clamp forceps ; BREWER
Hemostatic forceps , KELLY , 14cm
Hemostatic forceps , KELLY , 14cm , Curved
Cheek retractors , CAEWOOD-MINNESOTA , 16cm
Crown Scissors , BEEBEE , 10.5 cm
Gum Scissors , LA-GRANGE , 11,5 cm , Sharp-Sharp , S-shape.
Root Elevators , FLOHR L
Root Elevators , CRYER L
Raspatories , FREER , 18.5 cm
C.S. Mirror #4
C.S. Mirror #4 12 pack
C.S. Mirror #5
C.S. Mirror #5 12 Pack
Gracey Deep Pocket 1-2 xp 3/8" Resin
Gracey Deep Pocket 1-2 xp 3/8" Stainless
Gracey Deep Pocket 3-4 xp 3/8" Resin
Gracey Deep Pocket 3-4 xp 3/8" Stainless
Cassette SL5 (5 Instr)
Cassette SL5 (7 Instr - no rack)
Cassette 108(8 Instr)

Owner
Operator/Manufacturer(s)/Distributor(s)

RICK'S MEDICAL DEVICE FIRM(510k)786898(Manufacturer)

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Enter New Application Step 7

Cassette 108 utility (8 Instr)
Cassette 108 Removable Rack(8-16 Instr)
Cassette 109 W/12 Slots
Owner
Operator/Manufacturer(s)/Distributor(s)

Products
✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

Extracting forceps , American Pattern , Fig A 151 S
Pillers , Endo noteched Locking
Needle holders, CRILE-WOOD , 15cm
Needle holders, DERF , 12.5cm
Needle holders, MAYO-HEGAR , 16cm
Rubberdam punch , IVORY
Rubberdam punch , AINSWORTH
Rubberdam clamp forceps ; BREWER
Hemostatic forceps , KELLY , 14cm
Hemostatic forceps , KELLY , 14cm , Curved
Cheek retractors , CAEWOOD-MINNESOTA , 16cm
Crown Scissors , BEEBEE , 10.5 cm
Gum Scissors , LA-GRANGE , 11,5 cm , Sharp-Sharp , Sshape.
Root Elevators , FLOHR L
Root Elevators , CRYER L
Raspatories , FREER , 18.5 cm
C.S. Mirror #4
C.S. Mirror #4 12 pack
C.S. Mirror #5
C.S. Mirror #5 12 Pack
Gracey Deep Pocket 1-2 xp 3/8" Resin
Gracey Deep Pocket 1-2 xp 3/8" Stainless
Gracey Deep Pocket 3-4 xp 3/8" Resin
Gracey Deep Pocket 3-4 xp 3/8" Stainless
Cassette SL5 (5 Instr)
Cassette SL5 (7 Instr - no rack)
Cassette 108(8 Instr)
Cassette 108 utility (8 Instr)
Cassette 108 Removable Rack(8-16 Instr)
Cassette 109 W/12 Slots

Manufacturer(s)
RICK'S MEDICAL DEVICE
FIRM(510k)-786898
Distributor(s)
RICK'S MEDICAL DEVICE
FIRM(510k)-786898

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Enter New Application Step 7

This section allows you to associate each product or product listing to one or more facilities that have been
identified to be printed on the certificate. The associations you create will impact the printout of your
certificate.
Select one or multiple products from each page. Then select one or more facilities. When you are finished,
click on "Group". Continue grouping the remaining products until all products from the first page has been
grouped. Click on the "Next" hyperlink to continue to the next set of products (if available).
NOTE: You must associate each product to at least one facility. If there are multiple pages of products, you
must associate the products for each page before continuing to the next page of products.
Refer to the online help for more detailed instructions on product groupings and an example of a certificate
printout.

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

✔

Owner
Operator/Manufacturer(s)/Distributor(s)

Products

✔

Probe 1 Yellow 7/32" stainless
Probe 1 Yellow 3/8 " Resin
Probe 12 Yellow 7/32 " Resin
Probe 12 Yellow 7/32 " Stainless
Explorer 23 (SE) 3/8" Resin
Explorer 2 (DE) 3/8" Resin
Explorer 3 (SE) 7/32" Stainless
Curette Columbia 12-14 xp 3/8" Resin
Curette Columbia 12-14 xp 3/8" Stainless
Curette Columbia 12-14 xp 7/32" Resin
Waxing PKT 1 1/4" Stainless

✔

✔

Manufacturer(s)
RICK'S MEDICAL DEVICE
FIRM(510k)-786898
Distributor(s)
RICK'S MEDICAL DEVICE
FIRM(510k)-786898

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Enter New Application Step 7

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Enter New Application Step 7

Products
Owner Operator/Manufacturer(s)/Distributor(s)
Extracting forceps , American Pattern , Fig A 151 S
RICK'S MEDICAL DEVICE FIRM(510k)Pillers , Endo noteched Locking
786898(Manufacturer)
Needle holders, CRILE-WOOD , 15cm
Needle holders, DERF , 12.5cm
Needle holders, MAYO-HEGAR , 16cm
Rubberdam punch , IVORY
Rubberdam punch , AINSWORTH
Rubberdam clamp forceps ; BREWER
Hemostatic forceps , KELLY , 14cm
Hemostatic forceps , KELLY , 14cm , Curved
Cheek retractors , CAEWOOD-MINNESOTA , 16cm
Crown Scissors , BEEBEE , 10.5 cm
Gum Scissors , LA-GRANGE , 11,5 cm , Sharp-Sharp ,
S-shape.
Root Elevators , FLOHR L
Root Elevators , CRYER L
Raspatories , FREER , 18.5 cm
C.S. Mirror #4
C.S. Mirror #4 12 pack
C.S. Mirror #5
C.S. Mirror #5 12 Pack
Gracey Deep Pocket 1-2 xp 3/8" Resin
Gracey Deep Pocket 1-2 xp 3/8" Stainless
Gracey Deep Pocket 3-4 xp 3/8" Resin
Gracey Deep Pocket 3-4 xp 3/8" Stainless
Cassette SL5 (5 Instr)
Cassette SL5 (7 Instr - no rack)
Cassette 108(8 Instr)
Cassette 108 utility (8 Instr)
Cassette 108 Removable Rack(8-16 Instr)
Cassette 109 W/12 Slots
Probe 1 Yellow 7/32" stainless
RICK'S MEDICAL DEVICE FIRM(510k)Probe 1 Yellow 3/8 " Resin
786898(Manufacturer)
Probe 12 Yellow 7/32 " Resin
RICK'S MEDICAL DEVICE FIRM(510k)Probe 12 Yellow 7/32 " Stainless
786898(Distributor)
Explorer 23 (SE) 3/8" Resin
Explorer 2 (DE) 3/8" Resin
Explorer 3 (SE) 7/32" Stainless
Curette Columbia 12-14 xp 3/8" Resin
Curette Columbia 12-14 xp 3/8" Stainless
Curette Columbia 12-14 xp 7/32" Resin

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Enter New Application Step 7

Waxing PKT 1 1/4" Stainless

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Enter New Application Step 8

( Note : CDRH does not list a specific country on a certificate.)
Should the country destination be listed on the certificate ?
Yes
Indicate the total number of certificates requested : 12

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No

Enter New Application Step 8

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Enter New Application Step 9

Department of Health and Human Services EXPORTER'S CERTIFICATION STATEMENT "CERTIFICATE
Food and Drug Administration
TO FOREIGN GOVERNMENT " for CDRH
Primary Facility : RICK'S MEDICAL DEVICE FIRM(510k) - Manufacturer
As a responsible official or designee authorized to represent and act on behalf of the facility
named immediately above, I hereby certify to the Food and Drug Administration (FDA) that
the facility(s) and the products identified on the Supplemental Information are to the best of
my knowledge in substantial compliance with the Federal Food, Drug, and Cosmetic Act (the
Act) and all applicable or pertinent regulations including the following:
1. All Facilities that appear on the certificate are currently registered and each facility has
listed each of its medical devices identified for export as required by Section 510 of the
Act and 21 CFR Part 807 (See attached Supplementary Information Page);
2. Each product(s) identified for export is legally marketed within the United States and is
the subject of a 510(k) premarket notification or is a device that was in commercial
distribution before May 28, 1976, or exempt, or is the subject of a premarket approval
application;
3. Each product(s) identified is not subject of an open recall or the subject of any current
enforcement action initiated by FDA ; and
4. All manufacturers, contract manufacturers, and contract sterilizers involved in the
manufacturing process have been identified on the 3613 form.
5. The requesting facility and all facilities involved in the manufacturing process are
operating in substantial compliance with the Good Manufacturing Practices Regulation (21
CFR Part 820) for the identified product(s).
6. There are no HIV products listed on the certificate.
7. Each product(s) identified for export is being exported from the United States.
I hereby make this certification of compliance statement to FDA with full knowledge that the
making or submission of false statements represents violations of United State Code Title 18,
Chapter 47, Section 1001.Penalties include up to $250,000 in fines and up to five years of
imprisonment.
*I Agree

Date : 08/31/2012

*Name :
*Title : Test Title

Test Name

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Enter New Application Step 9

Each facility intended to be printed on the certificate must have a corresponding Exporter/'s Certification
Statement (ECS). Please upload the ECS to the corresponding facility. You will not be able to submit the
application without the ECS for each facility.
If you do not have the ECS, click on the "Save & Exit" button and return to the application when you have the
necessary documentation.
NOTE: The ECS attachment cannot exceed 50MB (Megabytes).
The total file size of all ECS attachments cannot exceed 50MB (Megabytes).
The accepted file formats include pdf, bmp, jpeg, gif, png, tiff, doc, and docx.

Name of the Distributor(s)
*RICK'S MEDICAL DEVICE
FIRM(510k)

no file selected

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Enter New Application Step 9

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Enter New Application Step 9

Each facility intended to be printed on the certificate must have a corresponding Exporter/'s Certification
Statement (ECS). Please upload the ECS to the corresponding facility. You will not be able to submit the
application without the ECS for each facility.
If you do not have the ECS, click on the "Save & Exit" button and return to the application when you have the
necessary documentation.
NOTE: The ECS attachment cannot exceed 50MB (Megabytes).
The total file size of all ECS attachments cannot exceed 50MB (Megabytes).
The accepted file formats include pdf, bmp, jpeg, gif, png, tiff, doc, and docx.

Name of the Distributor(s)
*RICK'S MEDICAL DEVICE
FIRM(510k)

1346441380299_162-8-2012_cert.pdf  

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Enter New Application Step 9

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Enter New Application Review

Please review your application. If all information is correct, click the Submit button below. To make changes to a
section, click the Edit button for that section.
Date: 08/31/2012
Created Date: 08/31/2012

Certificate Type: Certificate to Foreign Government (CFG)

Name :Mr.  Vijay   Maringanti

Address : 11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

Firm : gnsi

Telephone number : 3014656565  

Firm Tax ID code : 12 1211111

FAX Number :  

Firm : GNSI - Class I Exempt Only With Inspection

Email address :
vijayasarathi.maringanti@fda.
hhs.gov

Registration number :

Address (P.O. Box not acceptable): 311 W Side Dr Apt 301 ,
Gaithersburg , Maryland
UNITED STATES , 20878

License number :

Date of Last FDA inspection : 03/01/2011  

Firm : RICK'S MEDICAL DEVICE FIRM(510k)
Registration number : 786898  

Address (P.O. Box not acceptable) : 11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

License number (if applicable) :

Date of Last FDA inspection :  

Firm : RICK'S MEDICAL DEVICE FIRM(510k)

Address (P.O. Box not acceptable) : 11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

Registration number : 786898  

Will you be listing any refurbished or remanufactured products in this certificate?
Are you the original manufacturer of this product(s)?
This product(s) cannot be included on this application
Trade name
tn1

Yes

Yes

No

No
Proper name
pn1

Marketing Status Exempt  

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Enter New Application Review

Proper name
Proper Name2

Trade name
Trade Name2

Marketing status K991735  

Proper name
Proper Name3

Trade name
Trade Name3

Marketing status K974749  

If "Yes" State the recall number
and close-out date
✔

Yes  

NO  

Recall Number

Close-out Date :

Z-1039-05  

Trade name
tn1

Proper name
pn1

Close-out Letter details :

Yes  

✔

NO  

Proper name
Proper Name2

Trade name
Trade Name2

Yes  

✔

NO  

Trade name
Trade Name3

Proper name
Proper Name3

AFGHANISTAN 
ALAND ISLANDS 

Manufacturer

Header Name

SubHeader Name

RICK'S MEDICAL DEVICE FIRM(510k)

Name of Owner Operator

Formerly Known As

Distributor

Header Name

SubHeader Name

RICK'S MEDICAL DEVICE FIRM(510k)

Name of Distributor

Manufactured For

Products Grouping
Extracting forceps , American Pattern , Fig A 151 S
Pillers , Endo noteched Locking
Needle holders, CRILE-WOOD , 15cm
Needle holders, DERF , 12.5cm
Needle holders, MAYO-HEGAR , 16cm
Rubberdam punch , IVORY
Rubberdam punch , AINSWORTH
Rubberdam clamp forceps ; BREWER

RICK'S MEDICAL DEVICE FIRM(510k)786898(Manufacturer)

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Enter New Application Review
Hemostatic forceps , KELLY , 14cm
Hemostatic forceps , KELLY , 14cm , Curved
Cheek retractors , CAEWOOD-MINNESOTA , 16cm
Crown Scissors , BEEBEE , 10.5 cm
Gum Scissors , LA-GRANGE , 11,5 cm , Sharp-Sharp , S-shape.
Root Elevators , FLOHR L
Root Elevators , CRYER L
Raspatories , FREER , 18.5 cm
C.S. Mirror #4
C.S. Mirror #4 12 pack
C.S. Mirror #5
C.S. Mirror #5 12 Pack
Gracey Deep Pocket 1-2 xp 3/8" Resin
Gracey Deep Pocket 1-2 xp 3/8" Stainless
Gracey Deep Pocket 3-4 xp 3/8" Resin
Gracey Deep Pocket 3-4 xp 3/8" Stainless
Cassette SL5 (5 Instr)
Cassette SL5 (7 Instr - no rack)
Cassette 108(8 Instr)
Cassette 108 utility (8 Instr)
Cassette 108 Removable Rack(8-16 Instr)
Cassette 109 W/12 Slots

RICK'S MEDICAL DEVICE FIRM(510k)786898(Manufacturer)
RICK'S MEDICAL DEVICE FIRM(510k)786898(Distributor)

Probe 1 Yellow 7/32" stainless
Probe 1 Yellow 3/8 " Resin
Probe 12 Yellow 7/32 " Resin
Probe 12 Yellow 7/32 " Stainless
Explorer 23 (SE) 3/8" Resin
Explorer 2 (DE) 3/8" Resin
Explorer 3 (SE) 7/32" Stainless
Curette Columbia 12-14 xp 3/8" Resin
Curette Columbia 12-14 xp 3/8" Stainless
Curette Columbia 12-14 xp 7/32" Resin
Waxing PKT 1 1/4" Stainless

( Note : CDRH does not list a specific country on a certificate.)
Should the country destination be listed on the certificate ?

Yes

No

Indicate the total number of certificates requested: 12

The undersigned verifies that all ingredients are approved for use by FDA or appear on the GRAS list, and each product is
intended for human consumption and is available for sale in the U.S. without restriction.
Primary Facility : RICK'S MEDICAL DEVICE FIRM(510k) - Manufacturer
Name: Test Name
Title: Test Title
I Agree

Date:  08/31/2012

RICK'S MEDICAL DEVICE
FIRM(510k)

1346441380299_162-8-2012_cert.pdf 
Not For Public Disclosure

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Enter New Application Review

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Enter New Application Success

Your Application Number is 337-8-2012
Please keep the Application number for your records. The Application number is required for all
communications with FDA regarding this application. Please refer to the help section for more
details.
Note: Processing the application will not begin until a complete request package has been
received.

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Enter New Application Success

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View Application

Date : 08/31/2012
Created Date: 08/31/2012

Certificate Type : Certificate to Foreign Government (CFG)

Application Number : 337-8-2012

Application Status : Received

Name :Mr.  Vijay   Maringanti

Address : 11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

Firm : gnsi

Telephone Number : 3014656565  

Firm Tax ID code:   12 1211111

FAX Number:    

Firm:   GNSI - Class I Exempt Only With Inspection

Email address:  
vijayasarathi.maringanti@fda.
hhs.gov

Registration number:  

Address (P.O. Box not acceptable):   311 W Side Dr Apt 301 ,
Gaithersburg , Maryland
UNITED STATES , 20878

License number (if applicable):  

Date of Last FDA inspection:   03/01/2011  

Firm:   RICK'S MEDICAL DEVICE FIRM(510k)
Registration number:   786898  

Address (P.O. Box not acceptable:   11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

Will you be listing any refurbished or remanufactured products in this certificate?
Are you the original manufacturer of this product(s)?
This product(s) cannot be included on this application

Yes

No

No
Proper name
pn1

Trade name
tn1

Marketing status Exempt  

Trade name
Trade Name3

Yes

Proper name
Proper Name3

Marketing status K974749  

http://access.dev.fda.gov/cecats/viewApplication-flow.htm?execution=e2s1[8/31/2012 3:31:04 PM]

View Application
Trade name
Trade Name2

Proper name
Proper Name2

Marketing status K991735  

If "Yes" State the recall number
and close-out date
✔

Yes  

NO  

Recall number

Close-out Date:  

Z-1039-05  

Trade name
tn1

Proper name
pn1

Close-out Letter details :

Yes  

✔

NO  

Trade name
Trade Name3

Yes  

✔

NO  

Proper name
Proper Name3

Trade name
Trade Name2

Proper name
Proper Name2

ALAND ISLANDS 
AFGHANISTAN 

Manufacturer

Header Name

SubHeader Name

RICK'S MEDICAL DEVICE FIRM(510k)

Name of Owner Operator

Formerly Known As

Distributor

Header Name

SubHeader Name

RICK'S MEDICAL DEVICE FIRM(510k)

Name of Distributor

Manufactured For

Products Grouping
Extracting forceps , American Pattern , Fig A 151 S
Pillers , Endo noteched Locking
Needle holders, CRILE-WOOD , 15cm
Needle holders, DERF , 12.5cm
Needle holders, MAYO-HEGAR , 16cm
Rubberdam punch , IVORY
Rubberdam punch , AINSWORTH
Rubberdam clamp forceps ; BREWER
Hemostatic forceps , KELLY , 14cm
Hemostatic forceps , KELLY , 14cm , Curved
Cheek retractors , CAEWOOD-MINNESOTA , 16cm
Crown Scissors , BEEBEE , 10.5 cm
Gum Scissors , LA-GRANGE , 11,5 cm , Sharp-Sharp , S-shape.
Root Elevators , FLOHR L
Root Elevators , CRYER L

http://access.dev.fda.gov/cecats/viewApplication-flow.htm?execution=e2s1[8/31/2012 3:31:04 PM]

RICK'S MEDICAL DEVICE FIRM(510k)786898 (Manufacturer)

View Application
Raspatories , FREER , 18.5 cm
C.S. Mirror #4
C.S. Mirror #4 12 pack
C.S. Mirror #5
C.S. Mirror #5 12 Pack
Gracey Deep Pocket 1-2 xp 3/8" Resin
Gracey Deep Pocket 1-2 xp 3/8" Stainless
Gracey Deep Pocket 3-4 xp 3/8" Resin
Gracey Deep Pocket 3-4 xp 3/8" Stainless
Cassette SL5 (5 Instr)
Cassette SL5 (7 Instr - no rack)
Cassette 108(8 Instr)
Cassette 108 utility (8 Instr)
Cassette 108 Removable Rack(8-16 Instr)
Cassette 109 W/12 Slots

RICK'S MEDICAL DEVICE FIRM(510k)786898 (Manufacturer)
RICK'S MEDICAL DEVICE FIRM(510k)786898 (Distributor)

Probe 1 Yellow 7/32" stainless
Probe 1 Yellow 3/8 " Resin
Probe 12 Yellow 7/32 " Resin
Probe 12 Yellow 7/32 " Stainless
Explorer 23 (SE) 3/8" Resin
Explorer 2 (DE) 3/8" Resin
Explorer 3 (SE) 7/32" Stainless
Curette Columbia 12-14 xp 3/8" Resin
Curette Columbia 12-14 xp 3/8" Stainless
Curette Columbia 12-14 xp 7/32" Resin
Waxing PKT 1 1/4" Stainless

( Note : CDRH does not list a specific country on a certificate.)
Should the country destination be listed on the certificate?

Yes

No

Indicate the total number of certificates requested:   12

The undersigned verifies that all ingredients are approved for use by FDA or appear on the GRAS list, and each product is
intended for human consumption and is available for sale in the U.S. without restriction.
Primary facility:   RICK'S MEDICAL DEVICE FIRM(510k)-Manufacturer
Name:   Test Name
Title:   Test Title
I Agree

RICK'S MEDICAL DEVICE FIRM(510k)

Date:   08/31/2012
1346441380299_162-8-2012_cert.pdf
Not For Public Disclosure

http://access.dev.fda.gov/cecats/viewApplication-flow.htm?execution=e2s1[8/31/2012 3:31:04 PM]

CECATS - Search Application

SEARCH APPLICATION

APPLICATION
NUMBER:
REGISTRATION
NUMBER:
OWNER
OPERATOR
NUMBER:
FACILITY NAME

Manufacturer
Manufacturer

ADDRESS, LINE 1:
ADDRESS, LINE 2:
CITY:
STATE /
PROVINCE
/TERRITORY:

Click here to select a State / Province / Territory

ZIP:
COUNTRY/AREA:

--Pleaseselect
select
Country---Please
Country--

APPLICATION
STATUS:

Received
Received

http://access.dev.fda.gov/cecats/searchApplication-flow.htm?execution=e3s1[8/31/2012 3:31:23 PM]

SEARCH APPLICATION RESULT

SEARCH APPLICATIONS - SEARCH RESULTS

Search Results -    Total Applications: 1
The following Applications match your search criteria. You can use the up and down arrows to sort the
application list.
Page 1 of 1
 Application Number 
337-8-2012

 Date Of Application 
2012-08-31 15:30:31.0

 Status 
Received

http://access.dev.fda.gov/cecats/searchApplication-flow.htm?execution=e3s2[8/31/2012 3:31:40 PM]

 Certificate Type 
Certificate to Foreign Government
(CFG)

Modify Application

Please select from the following options

*Modify Options :
Update Recall Close-out Letter / ECS Document
Update the number of Certificates
Cancel the application

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s1[8/31/2012 3:31:58 PM]

Modify Application

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s1[8/31/2012 3:31:58 PM]

Modify Application

Please select from the following options

*Modify Options :
Update Recall Close-out Letter / ECS Document
Update the number of Certificates
Cancel the application

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s1[8/31/2012 3:34:09 PM]

Modify Application

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s1[8/31/2012 3:34:09 PM]

Enter New Application Step 1

Select

Application
Number
337-8-2012

Date of
Application
08/31/2012

Certificate Type
Certificate to Foreign
Government (CFG)

Status
Return for Action

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s2[8/31/2012 3:34:23 PM]

Enter New Application Step 1

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s2[8/31/2012 3:34:23 PM]

Enter New Application Review

Please review your application. If all information is correct, click the Submit button below. To make changes to a
section, click the Edit button for that section.
Date: 08/31/2012
Created Date: 08/31/2012

Certificate Type : Certificate to Foreign Government (CFG)

Application Number : 337-8-2012

Application Status : Return for Action

Name :Mr.  Vijay   Maringanti

Address : 11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

Firm : gnsi

Telephone number : 3014656565  

Firm Tax ID code : 12 1211111

FAX Number :  

Firm: GNSI - Class I Exempt Only With Inspection

Email address :
vijayasarathi.maringanti@fda.
hhs.gov

Registration number:

Address (P.O Box not acceptable): 311 W Side Dr Apt 301 ,
Gaithersburg , Maryland
UNITED STATES , 20878

License number (if applicable):

Date of Last FDA inspection: 03/01/2011  

Firm:   RICK'S MEDICAL DEVICE FIRM(510k)
Registration number:   786898  

Address (P.O. Box not acceptable):   11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

Will you be listing any refurbished or remanufactured products in this certificate?
Are you the original manufacturer of this product(s)?
This product(s) cannot be included on this application

Yes

Yes

No

No

Trade name
tn1

Marketing status Exempt  

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s3[8/31/2012 3:34:36 PM]

Proper name
pn1

Enter New Application Review
If "Yes" State the recall number
and close-out date
✔

Yes  

NO  

Close-out Letter details :

Recall Number

Close-out Date:  

Z-1039-05  

AFGHANISTAN 
ALAND ISLANDS 

Manufacturer

Header Name

SubHeader Name

RICK'S MEDICAL DEVICE FIRM(510k)

Name of Owner Operator

Formerly Known As

Distributor

Header Name

SubHeader Name

RICK'S MEDICAL DEVICE FIRM(510k)

Name of Distributor

Manufactured For

Products Grouping
RICK'S MEDICAL DEVICE FIRM(510k)786898 (Manufacturer)

Extracting forceps , American Pattern , Fig A 151 S
Pillers , Endo noteched Locking
Needle holders, CRILE-WOOD , 15cm
Needle holders, DERF , 12.5cm
Needle holders, MAYO-HEGAR , 16cm
Rubberdam punch , IVORY
Rubberdam punch , AINSWORTH
Rubberdam clamp forceps ; BREWER
Hemostatic forceps , KELLY , 14cm
Hemostatic forceps , KELLY , 14cm , Curved
Cheek retractors , CAEWOOD-MINNESOTA , 16cm
Crown Scissors , BEEBEE , 10.5 cm
Gum Scissors , LA-GRANGE , 11,5 cm , Sharp-Sharp , S-shape.
Root Elevators , FLOHR L
Root Elevators , CRYER L
Raspatories , FREER , 18.5 cm
C.S. Mirror #4
C.S. Mirror #4 12 pack
C.S. Mirror #5
C.S. Mirror #5 12 Pack
Gracey Deep Pocket 1-2 xp 3/8" Resin
Gracey Deep Pocket 1-2 xp 3/8" Stainless
Gracey Deep Pocket 3-4 xp 3/8" Resin
Gracey Deep Pocket 3-4 xp 3/8" Stainless
Cassette SL5 (5 Instr)
Cassette SL5 (7 Instr - no rack)
Cassette 108(8 Instr)
Cassette 108 utility (8 Instr)
Cassette 108 Removable Rack(8-16 Instr)
Cassette 109 W/12 Slots

( Note : CDRH does not list a specific country on a certificate.)
Should the country destination be listed on the certificate ?

Yes

No

Indicate the total number of certificates requested:   12

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s3[8/31/2012 3:34:36 PM]

Enter New Application Review

The undersigned verifies that all ingredients are approved for use by FDA or appear on the GRAS list, and each product is
intended for human consumption and is available for sale in the U.S. without restriction.
Primary Facility:   RICK'S MEDICAL DEVICE FIRM(510k)-Manufacturer
Name:   Test Name
Title:   Test Title
I Agree

Date:  08/31/2012

RICK'S MEDICAL DEVICE
FIRM(510k)

1346441380299_162-8-2012_cert.pdf 
Not For Public Disclosure

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s3[8/31/2012 3:34:36 PM]

Enter New Application Step 9

Each facility intended to be printed on the certificate must have a corresponding Exporter/'s Certification
Statement (ECS). Please upload the ECS to the corresponding facility. You will not be able to submit the
application without the ECS for each facility.
If you do not have the ECS, click on the "Save & Exit" button and return to the application when you have the
necessary documentation.
NOTE: The ECS attachment cannot exceed 50MB (Megabytes).
The total file size of all ECS attachments cannot exceed 50MB (Megabytes).
The accepted file formats include pdf, bmp, jpeg, gif, png, tiff, doc, and docx.

Name of the Manufacturer(s)
RICK'S MEDICAL DEVICE FIRM(510k)

Name of the Distributor(s)
*RICK'S MEDICAL DEVICE
FIRM(510k)

no file selected

1346441380299_162-8-2012_cert.pdf  

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s4[8/31/2012 3:34:53 PM]

Enter New Application Step 9

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s4[8/31/2012 3:34:53 PM]

Modify Application Success

The Application Number 337-8-2012 is modified successfully

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s6[8/31/2012 3:35:11 PM]

Modify Application Success

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e4s6[8/31/2012 3:35:11 PM]

Modify Application

Please select from the following options

*Modify Options :
Update Recall Close-out Letter / ECS Document
Update the number of Certificates
Cancel the application

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e5s1[8/31/2012 3:35:32 PM]

Modify Application

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e5s1[8/31/2012 3:35:32 PM]

Enter New Application Step 1

Select

Application
Number

Date of
Application

Certificate Type

Status

337-8-2012

08/31/2012

Certificate to Foreign
Government (CFG)

Ready for Review

317-8-2012

08/29/2012

Certificate to Foreign
Government (CFG)

Ready for Review

221-8-2012

08/19/2012

Certificate to Foreign
Government (CFG)

Ready for Review

262-8-2012

08/22/2012

Certificate to Foreign
Government (CFG)

Ready for Review

225-8-2012

08/20/2012

Certificate to Foreign
Government (CFG)

Ready for Review

213-8-2012

08/16/2012

Certificate to Foreign
Government (CFG)

Ready for Review

331-8-2012

08/31/2012

Certificate to Foreign
Government (CFG)

Ready for Review

311-8-2012

08/29/2012

Certificate to Foreign
Government (CFG)

Ready for Review

238-8-2012

08/20/2012

Certificate to Foreign
Government (CFG)

Ready for Review

288-8-2012

08/30/2012

Certificate to Foreign
Government (CFG)

Ready for Review

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e5s2[8/31/2012 3:35:45 PM]

Enter New Application Step 1

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e5s2[8/31/2012 3:35:45 PM]

Enter New Application Review

Please review your application. If all information is correct, click the Submit button below. To make changes to a
section, click the Edit button for that section.
Date: 08/31/2012
Created Date: 08/31/2012

Certificate Type : Certificate to Foreign Government (CFG)

Application Number : 337-8-2012

Application Status : Ready for Review

Name :Mr.  Vijay   Maringanti

Address : 11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

Firm : gnsi

Telephone number : 3014656565  

Firm Tax ID code : 12 1211111

FAX Number :  

Firm: RICK'S MEDICAL DEVICE FIRM(510k)

Email address :
vijayasarathi.maringanti@fda.
hhs.gov

Registration number: 786898

Address (P.O Box not acceptable): 11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

License number (if applicable):

Date of Last FDA inspection:  

Firm:   RICK'S MEDICAL DEVICE FIRM(510k)

Address (P.O. Box not acceptable):   11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

Registration number:   786898  

Will you be listing any refurbished or remanufactured products in this certificate?
Are you the original manufacturer of this product(s)?
This product(s) cannot be included on this application

Yes

Yes

No

No

Trade name
Trade Name3

Marketing status K974749  

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e5s3[8/31/2012 3:35:58 PM]

Proper name
Proper Name3

Enter New Application Review
If "Yes" State the recall number
and close-out date
Yes  

✔

NO  

Recall Number

Close-out Date:  

ALAND ISLANDS 
AFGHANISTAN 

Manufacturer

Header Name

SubHeader Name

RICK'S MEDICAL DEVICE FIRM(510k)

Name of Owner Operator

Formerly Known As

Distributor

Header Name

SubHeader Name

RICK'S MEDICAL DEVICE FIRM(510k)

Name of Distributor

Manufactured For

Products Grouping
RICK'S MEDICAL DEVICE FIRM(510k)786898 (Manufacturer)

Extracting forceps , American Pattern , Fig A 151 S
Pillers , Endo noteched Locking
Needle holders, CRILE-WOOD , 15cm
Needle holders, DERF , 12.5cm
Needle holders, MAYO-HEGAR , 16cm
Rubberdam punch , IVORY
Rubberdam punch , AINSWORTH
Rubberdam clamp forceps ; BREWER
Hemostatic forceps , KELLY , 14cm
Hemostatic forceps , KELLY , 14cm , Curved
Cheek retractors , CAEWOOD-MINNESOTA , 16cm
Crown Scissors , BEEBEE , 10.5 cm
Gum Scissors , LA-GRANGE , 11,5 cm , Sharp-Sharp , S-shape.
Root Elevators , FLOHR L
Root Elevators , CRYER L
Raspatories , FREER , 18.5 cm
C.S. Mirror #4
C.S. Mirror #4 12 pack
C.S. Mirror #5
C.S. Mirror #5 12 Pack
Gracey Deep Pocket 1-2 xp 3/8" Resin
Gracey Deep Pocket 1-2 xp 3/8" Stainless
Gracey Deep Pocket 3-4 xp 3/8" Resin
Gracey Deep Pocket 3-4 xp 3/8" Stainless
Cassette SL5 (5 Instr)
Cassette SL5 (7 Instr - no rack)
Cassette 108(8 Instr)
Cassette 108 utility (8 Instr)
Cassette 108 Removable Rack(8-16 Instr)
Cassette 109 W/12 Slots

( Note : CDRH does not list a specific country on a certificate.)
Should the country destination be listed on the certificate ?

Yes

No

Indicate the total number of certificates requested:   12

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e5s3[8/31/2012 3:35:58 PM]

Enter New Application Review
The undersigned verifies that all ingredients are approved for use by FDA or appear on the GRAS list, and each product is
intended for human consumption and is available for sale in the U.S. without restriction.
Primary Facility:   RICK'S MEDICAL DEVICE FIRM(510k)-Manufacturer
Name:   Test Name
Title:   Test Title
I Agree

Date:  08/31/2012

RICK'S MEDICAL DEVICE
FIRM(510k)

1346441380299_162-8-2012_cert.pdf 
Not For Public Disclosure

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e5s3[8/31/2012 3:35:58 PM]

Modify Application

( Note : CDRH does not list a specific country on a certificate.)
Should the country destination be listed on the certificate ?
Yes
Indicate the total number of certificates requested : 18

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e5s4[8/31/2012 3:36:20 PM]

No

Modify Application

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e5s4[8/31/2012 3:36:20 PM]

Enter New Application Review

Please review your application. If all information is correct, click the Submit button below. To make changes to a
section, click the Edit button for that section.
Date: 08/31/2012
Created Date: 08/31/2012

Certificate Type : Certificate to Foreign Government (CFG)

Application Number : 337-8-2012

Application Status : Ready for Review

Name :Mr.  Vijay   Maringanti

Address : 11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

Firm : gnsi

Telephone number : 3014656565  

Firm Tax ID code : 12 1211111

FAX Number :  

Firm: RICK'S MEDICAL DEVICE FIRM(510k)

Email address :
vijayasarathi.maringanti@fda.
hhs.gov

Registration number: 786898

Address (P.O Box not acceptable): 11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

License number (if applicable):

Date of Last FDA inspection:  

Firm:   RICK'S MEDICAL DEVICE FIRM(510k)

Address (P.O. Box not acceptable):   11820 Parklawn Dr Ste 300 ,
Rockville , Maryland
UNITED STATES , 20852

Registration number:   786898  

Will you be listing any refurbished or remanufactured products in this certificate?
Are you the original manufacturer of this product(s)?
This product(s) cannot be included on this application

Yes

Yes

No

No

Trade name
Trade Name3

Marketing status K974749  

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e5s5[8/31/2012 3:36:34 PM]

Proper name
Proper Name3

Enter New Application Review
If "Yes" State the recall number
and close-out date
Yes  

✔

NO  

Recall Number

Close-out Date:  

ALAND ISLANDS 
AFGHANISTAN 

Manufacturer

Header Name

SubHeader Name

RICK'S MEDICAL DEVICE FIRM(510k)

Name of Owner Operator

Formerly Known As

Distributor

Header Name

SubHeader Name

RICK'S MEDICAL DEVICE FIRM(510k)

Name of Distributor

Manufactured For

Products Grouping
RICK'S MEDICAL DEVICE FIRM(510k)786898 (Manufacturer)

Extracting forceps , American Pattern , Fig A 151 S
Pillers , Endo noteched Locking
Needle holders, CRILE-WOOD , 15cm
Needle holders, DERF , 12.5cm
Needle holders, MAYO-HEGAR , 16cm
Rubberdam punch , IVORY
Rubberdam punch , AINSWORTH
Rubberdam clamp forceps ; BREWER
Hemostatic forceps , KELLY , 14cm
Hemostatic forceps , KELLY , 14cm , Curved
Cheek retractors , CAEWOOD-MINNESOTA , 16cm
Crown Scissors , BEEBEE , 10.5 cm
Gum Scissors , LA-GRANGE , 11,5 cm , Sharp-Sharp , S-shape.
Root Elevators , FLOHR L
Root Elevators , CRYER L
Raspatories , FREER , 18.5 cm
C.S. Mirror #4
C.S. Mirror #4 12 pack
C.S. Mirror #5
C.S. Mirror #5 12 Pack
Gracey Deep Pocket 1-2 xp 3/8" Resin
Gracey Deep Pocket 1-2 xp 3/8" Stainless
Gracey Deep Pocket 3-4 xp 3/8" Resin
Gracey Deep Pocket 3-4 xp 3/8" Stainless
Cassette SL5 (5 Instr)
Cassette SL5 (7 Instr - no rack)
Cassette 108(8 Instr)
Cassette 108 utility (8 Instr)
Cassette 108 Removable Rack(8-16 Instr)
Cassette 109 W/12 Slots

( Note : CDRH does not list a specific country on a certificate.)
Should the country destination be listed on the certificate ?

Yes

No

Indicate the total number of certificates requested:   18

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e5s5[8/31/2012 3:36:34 PM]

Enter New Application Review
The undersigned verifies that all ingredients are approved for use by FDA or appear on the GRAS list, and each product is
intended for human consumption and is available for sale in the U.S. without restriction.
Primary Facility:   RICK'S MEDICAL DEVICE FIRM(510k)-Manufacturer
Name:   Test Name
Title:   Test Title
I Agree

Date:  08/31/2012

RICK'S MEDICAL DEVICE
FIRM(510k)

1346441380299_162-8-2012_cert.pdf 
Not For Public Disclosure

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e5s5[8/31/2012 3:36:34 PM]

Modify Application

Please select from the following options

*Modify Options :
Update Recall Close-out Letter / ECS Document
Update the number of Certificates
Cancel the application

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e6s1[8/31/2012 3:36:54 PM]

Modify Application

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e6s1[8/31/2012 3:36:54 PM]

Enter New Application Step 1

Select

Application
Number

Date of
Application

Certificate Type

Status

311-8-2012

08/29/2012

Certificate to Foreign
Government (CFG)

Ready for Review

221-8-2012

08/19/2012

Certificate to Foreign
Government (CFG)

Ready for Review

337-8-2012

08/31/2012

Certificate to Foreign
Government (CFG)

Ready for Review

262-8-2012

08/22/2012

Certificate to Foreign
Government (CFG)

Ready for Review

317-8-2012

08/29/2012

Certificate to Foreign
Government (CFG)

Ready for Review

331-8-2012

08/31/2012

Certificate to Foreign
Government (CFG)

Ready for Review

238-8-2012

08/20/2012

Certificate to Foreign
Government (CFG)

Ready for Review

225-8-2012

08/20/2012

Certificate to Foreign
Government (CFG)

Ready for Review

288-8-2012

08/30/2012

Certificate to Foreign
Government (CFG)

Ready for Review

213-8-2012

08/16/2012

Certificate to Foreign
Government (CFG)

Ready for Review

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e6s2[8/31/2012 3:37:51 PM]

Enter New Application Step 1

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e6s2[8/31/2012 3:37:51 PM]

Enter New Application

The selected application will be cancelled.Do you wish to continue?

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e6s3[8/31/2012 3:38:04 PM]

Enter New Application

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e6s3[8/31/2012 3:38:04 PM]

Cancel Application Success

The Application Number 337-8-2012 is cancelled successfully

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e6s4[8/31/2012 3:38:23 PM]

Cancel Application Success

http://access.dev.fda.gov/cecats/modifyApplication-flow.htm?execution=e6s4[8/31/2012 3:38:23 PM]