Catalog Number

EPGC200H

Brand Name

BioStim Pre-Wried electrodes, Hypoallergenic

Version/Model Number

EPGC200H

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

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

9188c45b-994f-4b9c-8ee1-0a897be99f71

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

10857771003795

Quantity per Package

40

Contains DI Package

00857771003798

Package Discontinue Date

April 01, 2019

Package Status

Not in Commercial Distribution

Package Type

inner pack