Catalog Number

-

Brand Name

LIFESTYLES

Version/Model Number

0035

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

K001883,K001883,K001883

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

2dc89153-93d1-46f7-b27b-e92ccdf33796

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 2022

Package DI Number

10070907000356

Quantity per Package

7

Contains DI Package

30070907000350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER