Catalog Number

-

Brand Name

ELE-425

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

b879d86f-9e14-498e-accf-c370a0023a9f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 02, 2016

Package DI Number

00857398006356

Quantity per Package

10

Contains DI Package

00857398006172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag