Catalog Number

GM320PE

Brand Name

GEM-STIM

Version/Model Number

GM320PE

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

ab7b59ed-3ba3-4d5a-a7cf-0ee3cdce0768

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

September 23, 2016

Package DI Number

24712832960192

Quantity per Package

30

Contains DI Package

04712832960198

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton