Cadwell Disposable Surface Electrode - CADWELL INDUSTRIES, INC.

Duns Number:098554157

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More Product Details

Catalog Number

-

Brand Name

Cadwell Disposable Surface Electrode

Version/Model Number

302854-000-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Device Record Status

Public Device Record Key

df46f67d-8ac8-4c1b-a5a7-08ca33a06e08

Public Version Date

February 14, 2019

Public Version Number

5

DI Record Publish Date

September 05, 2016

Additional Identifiers

Package DI Number

10840067100889

Quantity per Package

24

Contains DI Package

00840067100882

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"CADWELL INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 290