Catalog Number

-

Brand Name

Durex RED Extra Sensitive 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,K980319,K980319

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

0b1ded14-01d7-4230-a919-d8fedde9c07f

Public Version Date

October 22, 2019

Public Version Number

1

DI Record Publish Date

October 14, 2019

Package DI Number

10302340995518

Quantity per Package

16

Contains DI Package

00302340995511

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton