Catalog Number

-

Brand Name

CVS Health

Version/Model Number

MDTS111

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

Yes

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

bdaf8f91-9076-4216-9745-b2e941668932

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

August 09, 2016

Package DI Number

10050428419967

Quantity per Package

24

Contains DI Package

00050428419960

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipping case