Cascade IOMAX Intraoperative Monitor

GUDID 00840067100639

Cascade IOMAX Base Module

CADWELL INDUSTRIES, INC.

Neurophysiologic monitoring system
Primary Device ID00840067100639
NIH Device Record Keybfc19c0d-7c2a-47f9-9b02-0f8c9cd664dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCascade IOMAX Intraoperative Monitor
Version Model Number190291-200
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 Numbertrue
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
GS100840067100639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-15
Device Publish Date2017-05-31

On-Brand Devices [Cascade IOMAX Intraoperative Monitor]

00840067100653Cascade IOMAX Cortical Module
00840067100646Cascade IOMAX Limb Module
00840067100639Cascade IOMAX Base Module
00840067102718IOMAX 3M VEP LED GOGGLES
00840067102763IOMAX 32 Channel Amplifier
00840067102220LCSwap IOMAX
00840067102053Cascade IOMAX VEP LED Goggles

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