Catalog Number

-

Brand Name

Carbon-Rubber Electrodes (8" x 3")

Version/Model Number

0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2019

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K002227

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

00d68f5f-3227-442f-a1c9-710769489595

Public Version Date

July 12, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-