Catalog Number

-

Brand Name

ACP High Conductivity Electrodes 3x5

Version/Model Number

26854

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

Yes

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

f28a786d-1432-48f0-992f-d1027c05828b

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

August 16, 2016

Package DI Number

10858703006174

Quantity per Package

10

Contains DI Package

00858703006177

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-