Catalog Number

100508

Brand Name

EPAD

Version/Model Number

EPAD

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 10, 2019

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

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

ffb350cc-c66d-4cb4-ba53-c7d85d4c79f3

Public Version Date

August 30, 2021

Public Version Number

3

DI Record Publish Date

December 14, 2016

Package DI Number

00851641007251

Quantity per Package

4

Contains DI Package

00851641007220

Package Discontinue Date

October 10, 2019

Package Status

Not in Commercial Distribution

Package Type

Case