Catalog Number

1570

Brand Name

Revitive Electrode Body Pads

Version/Model Number

1570

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

K132588,K132588,K132588

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

6eb06e15-5e56-4d9b-a50a-05dd7f5fa14c

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

April 23, 2018

Package DI Number

00858058005030

Quantity per Package

30

Contains DI Package

10858058005020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton