Catalog Number

-

Brand Name

Biowave Percutaneous Electrodes

Version/Model Number

MK78515 - BWEP02-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

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

K061166,K061166,K061166

Product Code

NHI

Product Code Name

Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief

Public Device Record Key

188f5f2c-28fc-4d40-a6e1-3e1aa56e723d

Public Version Date

December 23, 2019

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

10859911006024

Quantity per Package

6

Contains DI Package

00859911006027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

6-pack zip lock - E