Cadwell XL Monopolar Stimulating Probe - CADWELL INDUSTRIES, INC.

Duns Number:098554157

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More Product Details

Catalog Number

-

Brand Name

Cadwell XL Monopolar Stimulating Probe

Version/Model Number

302416-000

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

GXZ

Product Code Name

ELECTRODE, NEEDLE

Device Record Status

Public Device Record Key

e55e3d58-4af1-4dd8-b0e8-c2286e5c6f70

Public Version Date

February 14, 2019

Public Version Number

4

DI Record Publish Date

September 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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