Catalog Number

34650000BP-US

Brand Name

STOP VX MODEL U

Version/Model Number

STOP U MODEL UXV

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

K203665

Product Code

PAY

Product Code Name

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Public Device Record Key

8ac28c19-87bc-4b7c-98f3-c41d790afbc5

Public Version Date

July 08, 2021

Public Version Number

1

DI Record Publish Date

June 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-