Catalog Number

-

Brand Name

DUREX XXL 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

K122219,K122219,K122219,K122219

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

fe2b5889-f86f-4649-a142-d92e68bec0b2

Public Version Date

December 31, 2019

Public Version Number

1

DI Record Publish Date

December 23, 2019

Package DI Number

10302340300435

Quantity per Package

6

Contains DI Package

00302340300438

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton