Catalog Number

-

Brand Name

No

Version/Model Number

FM-B2404

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

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

a2a8cce4-1db9-4f5f-ba66-47ffa17e7897

Public Version Date

September 23, 2021

Public Version Number

3

DI Record Publish Date

June 15, 2021

Package DI Number

16973810850046

Quantity per Package

60

Contains DI Package

06973810850049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-