Catalog Number

WF120

Brand Name

Therapist’s Choice®

Version/Model Number

WF120

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

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

8d43f35f-b813-4c80-a3f4-b041898f91e9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 19, 2017

Package DI Number

00815290015586

Quantity per Package

5

Contains DI Package

00815290015579

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master case