Catalog Number

-

Brand Name

SKYN

Version/Model Number

5415

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

-

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

49eeab77-e283-4dff-ad6a-120be6b527be

Public Version Date

July 21, 2022

Public Version Number

7

DI Record Publish Date

July 17, 2017

Package DI Number

10070907254155

Quantity per Package

4

Contains DI Package

00070907254158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner