Cadwell EEG Gold Cup Electrode Pak - CADWELL INDUSTRIES, INC.

Duns Number:098554157

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More Product Details

Catalog Number

-

Brand Name

Cadwell EEG Gold Cup Electrode Pak

Version/Model Number

302691-200

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

-

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

K933808

Product Code Details

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Device Record Status

Public Device Record Key

35a3ae79-c318-48d9-8470-f155f7da2139

Public Version Date

July 06, 2018

Public Version Number

3

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