Catalog Number

-

Brand Name

AcuZone

Version/Model Number

AcuZone-40-2x4pigtail electrodes

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 12, 2025

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

Yes

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

632451f0-8dc0-4ac1-a8d6-b54fa5853f35

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

November 13, 2020

Package DI Number

16959006303312

Quantity per Package

34

Contains DI Package

06959006303315

Package Discontinue Date

November 11, 2025

Package Status

In Commercial Distribution

Package Type

PE POUCH