Catalog Number

-

Brand Name

Skyn

Version/Model Number

2442

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"

-

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

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

3583ae5f-dfb0-4ed9-9223-335b5d0bf73a

Public Version Date

August 07, 2020

Public Version Number

2

DI Record Publish Date

August 24, 2018

Package DI Number

30070907024424

Quantity per Package

6

Contains DI Package

10070907024420

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case