Catalog Number

-

Brand Name

Biowave Percutaneous Electrodes

Version/Model Number

MK78505 - BWEP01-B

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

6cc12c72-1775-4a81-a5aa-aeb4c1707c5c

Public Version Date

December 23, 2019

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

20859911006007

Quantity per Package

48

Contains DI Package

10859911006000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case - Perc B