Catalog Number

A0029_ME

Brand Name

SilkPeel Pro

Version/Model Number

A0029_ME

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

GFE

Product Code Name

Brush, Dermabrasion, Powered

Public Device Record Key

8f2095bb-935b-4166-88b8-6a9cf473b136

Public Version Date

March 29, 2021

Public Version Number

1

DI Record Publish Date

March 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-