Catalog Number

-

Brand Name

LIfestyles

Version/Model Number

9588

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

-

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

b1e610b0-988f-4560-b5f3-710fc361cd69

Public Version Date

October 11, 2021

Public Version Number

3

DI Record Publish Date

December 20, 2018

Package DI Number

30070907295886

Quantity per Package

6

Contains DI Package

10070907295882

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case