Catalog Number

MU73497

Brand Name

ComforTENS Plus

Version/Model Number

MU73497

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)

-

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

e2803543-1d99-4de8-b42c-7c7345c51e28

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

July 04, 2017

Package DI Number

20884521706269

Quantity per Package

48

Contains DI Package

10884521706262

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE