Catalog Number

KBSM7

Brand Name

BioStim M7

Version/Model Number

M7

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

e31e60b5-321d-4abc-8bc4-17ece8849afd

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10857771003221

Quantity per Package

60

Contains DI Package

00857771003224

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case