Catalog Number

TC5050-WF

Brand Name

Clinical Health Services, Inc.

Version/Model Number

TC5050-WF

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

-

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

27c4e3e8-b15f-45c7-a46a-48324ce33898

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

December 19, 2020

Package DI Number

10815290017648

Quantity per Package

10

Contains DI Package

00815290017641

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Bag