Catalog Number

5970

Brand Name

Revitive Medic

Version/Model Number

5573AQ

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

K190924,K190924

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

c2f50752-f026-4877-af74-1d426104752f

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

January 19, 2021

Package DI Number

10858058005235

Quantity per Package

6

Contains DI Package

00858058005238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer carton