Catalog Number

-

Brand Name

LIFESTYLES

Version/Model Number

3040

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K941258,K941258,K941258,K941258

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

ce637a7f-2362-403a-907c-53924e78fb36

Public Version Date

August 27, 2020

Public Version Number

2

DI Record Publish Date

December 06, 2019

Package DI Number

30070907230405

Quantity per Package

24

Contains DI Package

10070907230401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE