Catalog Number

-

Brand Name

Biowave Noninvasive Electrodes

Version/Model Number

MK78570 - BWEN02-E

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

cac838f0-b7c9-4717-8dcc-870a0704ee68

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

August 01, 2016

Package DI Number

20859911006090

Quantity per Package

250

Contains DI Package

10859911006093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case - E-set