Catalog Number

-

Brand Name

DUREX Prolong 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,K020659,K020659,K020659

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

1de6e650-8bc8-41ea-9b02-7224e75d1a36

Public Version Date

November 07, 2019

Public Version Number

1

DI Record Publish Date

October 30, 2019

Package DI Number

20302340971380

Quantity per Package

6

Contains DI Package

10302340971383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case