Catalog Number

GM320T(3)

Brand Name

GEM-STIM

Version/Model Number

GM320T(3)

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

b87d57db-d45c-4327-a178-b25e5f1c918e

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

September 23, 2016

Package DI Number

24712832960031

Quantity per Package

30

Contains DI Package

04712832960037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton