Catalog Number

-

Brand Name

SKYN

Version/Model Number

3118

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"

-

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

MOL

Product Code Name

Condom, Synthetic

Public Device Record Key

e8fbc8e1-3c7d-46f6-bcbf-ff61cfb0c9ce

Public Version Date

February 01, 2021

Public Version Number

1

DI Record Publish Date

January 22, 2021

Package DI Number

10070907231187

Quantity per Package

6

Contains DI Package

00070907231180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER