Catalog Number

FA5050

Brand Name

GEM-STIM

Version/Model Number

FA5050

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

b6846107-ad87-45d9-bee8-55b1280fdcff

Public Version Date

February 19, 2021

Public Version Number

9

DI Record Publish Date

September 23, 2016

Package DI Number

14712832960072

Quantity per Package

50

Contains DI Package

04712832960075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box