Catalog Number

KBSP

Brand Name

BioStim Plus

Version/Model Number

BioStim Plus

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 28, 2020

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

K022841,K022841

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

14f72057-5d03-4270-846b-02de8369398f

Public Version Date

January 28, 2020

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

10857771003078

Quantity per Package

60

Contains DI Package

00857771003071

Package Discontinue Date

January 28, 2020

Package Status

Not in Commercial Distribution

Package Type

-