Cadwell Clip-On Lead Wire - CADWELL INDUSTRIES, INC.

Duns Number:098554157

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More Product Details

Catalog Number

-

Brand Name

Cadwell Clip-On Lead Wire

Version/Model Number

302773-200

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

-

Product Code Details

Product Code

IKD

Product Code Name

CABLE, ELECTRODE

Device Record Status

Public Device Record Key

8306daff-6948-4c4e-aac0-94f72ac5eb0d

Public Version Date

April 20, 2021

Public Version Number

5

DI Record Publish Date

September 05, 2016

Additional Identifiers

Package DI Number

00840067103098

Quantity per Package

10

Contains DI Package

00840067100318

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"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