Catalog Number

-

Brand Name

DUREX Extra Sensitive Smooth 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,K980319

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

176f3a85-449d-426e-8083-12735dc310d4

Public Version Date

April 17, 2020

Public Version Number

1

DI Record Publish Date

April 09, 2020

Package DI Number

10067981160489

Quantity per Package

3

Contains DI Package

00067981160482

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton