Catalog Number

-

Brand Name

Revitive Electrode Body Pads

Version/Model Number

2044

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

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

ab133c65-7a8a-4198-9abc-d912c65713c6

Public Version Date

May 31, 2021

Public Version Number

2

DI Record Publish Date

May 04, 2021

Package DI Number

05060217492130

Quantity per Package

300

Contains DI Package

05060217490303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer carton