Catalog Number

-

Brand Name

LIFESTYLES

Version/Model Number

0937

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

-

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

1dc80046-e3c6-4b14-ab1a-4446ae72df41

Public Version Date

October 11, 2021

Public Version Number

7

DI Record Publish Date

July 11, 2016

Package DI Number

10070907209377

Quantity per Package

4

Contains DI Package

00070907209370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner