Catalog Number

KBSD

Brand Name

BioStim SD

Version/Model Number

SD

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 29, 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

-

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

1381bc6d-e444-4ef3-b440-f8efe491c285

Public Version Date

June 02, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

10857771003085

Quantity per Package

60

Contains DI Package

00857771003088

Package Discontinue Date

May 29, 2020

Package Status

Not in Commercial Distribution

Package Type

case