Catalog Number

REPS4560

Brand Name

RecoverPad

Version/Model Number

REPS4560

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 17, 2020

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

0c29260d-34a3-4fef-86ab-d93f1250e2c7

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

December 19, 2017

Package DI Number

10851610008163

Quantity per Package

200

Contains DI Package

00851610008166

Package Discontinue Date

September 17, 2020

Package Status

Not in Commercial Distribution

Package Type

Box