Catalog Number

-

Brand Name

Durex PleasureMax 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

K040185,K040185

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

3805cf3e-ef0c-4057-b1dc-2efe2e25030b

Public Version Date

December 13, 2018

Public Version Number

4

DI Record Publish Date

February 14, 2017

Package DI Number

10302340301913

Quantity per Package

1000

Contains DI Package

00302340301916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton