Catalog Number

-

Brand Name

B&L Engineering Active Surface EMG Electrode

Version/Model Number

BL-AE-W/NG

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

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

IKN

Product Code Name

Electromyograph, Diagnostic

Public Device Record Key

2ed0f8d8-2593-46bd-97d1-7605473d84cb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-