Catalog Number

PRO TENS

Brand Name

GEM-STIM

Version/Model Number

PRO TENS

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

defd5379-b1c6-4a4c-82c3-46d8134d90f0

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

October 03, 2016

Package DI Number

24712832960383

Quantity per Package

30

Contains DI Package

04712832960389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton