Catalog Number

-

Brand Name

GS27

Version/Model Number

Disposable ECG-EMG electrode

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"

-

For Single-Use

Yes

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

-

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

8a4ddd67-ba27-4aff-8def-15d9342c47f7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2017

Package DI Number

00857398006479

Quantity per Package

25

Contains DI Package

40857398006248

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-