Catalog Number

-

Brand Name

DUREX Pleasure Pack Condom

Version/Model Number

Condom

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

K020659,K081886,K980319,K020659,K081886,K980319,K020659,K081886,K980319,K020659,K081886,K980319

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

4aa3a5ac-8158-4e96-a924-d13264edf190

Public Version Date

March 13, 2020

Public Version Number

1

DI Record Publish Date

March 05, 2020

Package DI Number

10302340989333

Quantity per Package

3

Contains DI Package

00302340989336

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton