Catalog Number

-

Brand Name

SKYN

Version/Model Number

9739

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

-

Product Code

MOL

Product Code Name

Condom, Synthetic

Public Device Record Key

89533f94-f327-42c9-b33b-531f5ab4e9d0

Public Version Date

July 21, 2022

Public Version Number

5

DI Record Publish Date

July 11, 2016

Package DI Number

10070907297398

Quantity per Package

6

Contains DI Package

00070907297391

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER