Catalog Number

-

Brand Name

Cadwell Disposable Surface Electrode

Version/Model Number

302853-000-100

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K110289,K110289

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

67a3104a-cf4c-4ff9-b720-f14232f35bba

Public Version Date

February 14, 2019

Public Version Number

5

DI Record Publish Date

September 05, 2016

Package DI Number

10840067100865

Quantity per Package

24

Contains DI Package

00840067100868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box