Catalog Number

TC120R-WC

Brand Name

Clinical Health Services, Inc.

Version/Model Number

TC120R-WC

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

10738b62-d61e-4e94-99a3-49111c0b4a9e

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Package DI Number

10815290018881

Quantity per Package

10

Contains DI Package

00815290018884

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Bag