Catalog Number

LiftHG

Brand Name

SkinPen

Version/Model Number

1

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Public Device Record Key

d9fa908c-bad9-444e-9a5b-03f5aedbfa7d

Public Version Date

May 26, 2022

Public Version Number

4

DI Record Publish Date

November 08, 2018

Package DI Number

10863221000368

Quantity per Package

24

Contains DI Package

00863221000361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-