Catalog Number

-

Brand Name

LIFESTYLES

Version/Model Number

5300

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

K000408,K941258,K000408,K941258,K000408,K941258

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

b89af337-ca32-4651-9943-07ef48eacc30

Public Version Date

July 22, 2022

Public Version Number

7

DI Record Publish Date

July 11, 2016

Package DI Number

10070907000332

Quantity per Package

144

Contains DI Package

30070907053004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner