Catalog Number

-

Brand Name

ChoiceMMed

Version/Model Number

CTSW2A1

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)

Yes

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

ea6f43f8-c385-487a-925e-4e25d99f7524

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

July 17, 2017

Package DI Number

10846841013970

Quantity per Package

24

Contains DI Package

00846841013973

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-