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

K980319,K020659,K072169,K980319,K020659,K072169,K980319,K020659,K072169

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

542ad4fb-a58f-4ed3-aab3-0e36b5f16483

Public Version Date

March 12, 2020

Public Version Number

1

DI Record Publish Date

March 04, 2020

Package DI Number

10302340958834

Quantity per Package

18

Contains DI Package

00302340958837

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton