Catalog Number

-

Brand Name

LIFESTYLES

Version/Model Number

9803

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

8c50f34c-2356-4382-921c-956724a6eac5

Public Version Date

August 27, 2019

Public Version Number

6

DI Record Publish Date

July 11, 2016

Package DI Number

10070907098032

Quantity per Package

6

Contains DI Package

00070907098035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner