Cascade Elite - Cascade Elite - CADWELL INDUSTRIES, INC.

Duns Number:098554157

Device Description: Cascade Elite

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More Product Details

Catalog Number

-

Brand Name

Cascade Elite

Version/Model Number

190239-200

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"

-

For Single-Use

-

Prescription Use (Rx)

-

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

GWE

Product Code Name

Stimulator, photic, evoked response

Device Record Status

Public Device Record Key

c4c49509-e61b-4405-833d-68f4e82254db

Public Version Date

April 15, 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