Catalog Number

-

Brand Name

SKYN

Version/Model Number

3109

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

K160399,K171172,K160399,K171172,K160399,K171172

Product Code

MOL

Product Code Name

Condom, Synthetic

Public Device Record Key

531a66e3-5f06-47f0-91ce-c7eff4ddb5c9

Public Version Date

July 21, 2022

Public Version Number

2

DI Record Publish Date

August 26, 2020

Package DI Number

10070907231095

Quantity per Package

4

Contains DI Package

00070907231098

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER