Catalog Number

-

Brand Name

DUREX® FitLab 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

K200672,K980319,K200672,K980319,K200672,K980319

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

9568e7cd-98bd-4a43-af9a-8939e9beb285

Public Version Date

June 23, 2022

Public Version Number

1

DI Record Publish Date

June 15, 2022

Package DI Number

10302340010051

Quantity per Package

50

Contains DI Package

00302340010054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton