Catalog Number

700015-A

Brand Name

FaceMaster

Version/Model Number

Platinum

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K040871

Product Code

NFO

Product Code Name

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Public Device Record Key

d45049c8-6124-4f23-a0f4-d016a3743aa7

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

December 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-