Catalog Number

-

Brand Name

LIFESTYLES

Version/Model Number

7098

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

K001883,K941258,K001883,K941258,K001883,K941258

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

23ee53ac-7abd-41c8-9b34-dcad822ab438

Public Version Date

December 20, 2018

Public Version Number

5

DI Record Publish Date

July 17, 2017

Package DI Number

10070907270988

Quantity per Package

4

Contains DI Package

00070907270981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner