Catalog Number

TC50100-WF

Brand Name

Clinical Health Services, Inc.

Version/Model Number

TC50100-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

19308f15-9330-4f7e-a80e-dfb822d10ab8

Public Version Date

October 07, 2021

Public Version Number

1

DI Record Publish Date

September 29, 2021

Package DI Number

10815290018263

Quantity per Package

10

Contains DI Package

00815290018266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Bag