Cascade Elite

GUDID 00840067100578

Cascade VEP/LED Quick Connect Goggles

CADWELL INDUSTRIES, INC.

Neurophysiologic monitoring system
Primary Device ID00840067100578
NIH Device Record Key8a590495-c460-4d93-b041-8f6f74cab37e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCascade Elite
Version Model Number199253-200
Company DUNS098554157
Company NameCADWELL INDUSTRIES, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(509)735-6481
Emailapplications@cadwell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840067100578 [Primary]

FDA Product Code

OLTNon-normalizing quantitative electroencephalograph software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-15
Device Publish Date2016-09-05

On-Brand Devices [Cascade Elite]

00840067100578Cascade VEP/LED Quick Connect Goggles
00840067100271Cascade Elite
00840067100295Cascade Elite Power/Com Module

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