Catalog Number

-

Brand Name

SKYN

Version/Model Number

7312

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

MOL

Product Code Name

Condom, Synthetic

Public Device Record Key

79baf38f-02c3-4d24-b967-ebe3f098b3a9

Public Version Date

July 21, 2022

Public Version Number

7

DI Record Publish Date

June 16, 2016

Package DI Number

10070907273125

Quantity per Package

4

Contains DI Package

00070907273128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner