Catalog Number

-

Brand Name

SKYN

Version/Model Number

0059

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

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

K171172,K171172,K171172

Product Code

MOL

Product Code Name

Condom, Synthetic

Public Device Record Key

536a9908-0952-4ba4-afab-2ab366dcdb80

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 2022

Package DI Number

10070907000592

Quantity per Package

7

Contains DI Package

30070907000596

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER