Catalog Number

IDDCNDST

Brand Name

ID Condoms

Version/Model Number

ID Studded Condoms (Case/1000)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K910284,K910284,K910284

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

2d18f183-a8eb-431c-bf60-9e127d8f3073

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 09, 2017

Package DI Number

20761236110225

Quantity per Package

4

Contains DI Package

10761236110228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-