Catalog Number

-

Brand Name

SKYN

Version/Model Number

3003

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,K160399,K160399,K160399

Product Code

MOL

Product Code Name

Condom, Synthetic

Public Device Record Key

0ff4aaa2-1603-4b86-824b-65fc0951f563

Public Version Date

September 06, 2019

Public Version Number

1

DI Record Publish Date

August 29, 2019

Package DI Number

30070907230030

Quantity per Package

6

Contains DI Package

10070907230036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE