Catalog Number

-

Brand Name

LIFESTYLES

Version/Model Number

0080

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

K213921,K213921,K213921,K213921

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

ffcb8cbd-ca7e-405e-933c-c54a9da58b95

Public Version Date

July 13, 2022

Public Version Number

1

DI Record Publish Date

July 05, 2022

Package DI Number

10070907000790

Quantity per Package

4

Contains DI Package

00070907000809

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER