Catalog Number

-

Brand Name

Skyn

Version/Model Number

9318

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171172,K171172,K171172,K171172

Product Code

MOL

Product Code Name

Condom, Synthetic

Public Device Record Key

137004ab-8755-41fc-a0e5-b95e9ca26f08

Public Version Date

July 22, 2022

Public Version Number

3

DI Record Publish Date

December 20, 2018

Package DI Number

30070907293189

Quantity per Package

6

Contains DI Package

10070907293185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case