Catalog Number

-

Brand Name

N/A

Version/Model Number

ACRL-0002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

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

d4c08fb8-f083-43d7-a283-dbc081e94205

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 12, 2016

Package DI Number

50023601200025

Quantity per Package

8

Contains DI Package

30023601200021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA