FDA.reportPublic FDA data

Cascade IOMAX Intraoperative Monitor

Primary DI
00840067100646
Brand
Cascade IOMAX Intraoperative Monitor
Company
CADWELL INDUSTRIES, INC.
Model
190295-200
Device description
Cascade IOMAX Limb Module
Published
2017-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
ETNSTIMULATOR, NERVE
GWEStimulator, photic, evoked response
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE
GWJSTIMULATOR, AUDITORY, EVOKED RESPONSE
GWQFull-montage Standard Electroencephalograph
GZODEVICE, GALVANIC SKIN RESPONSE MEASUREMENT
IKNElectromyograph, diagnostic
JXEDEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT
OLTNon-normalizing quantitative electroencephalograph software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
ETNStimulator, NerveEar, Nose, Throat2
GWEStimulator, Photic, Evoked ResponseNeurology2
GWFStimulator, Electrical, Evoked ResponseNeurology2
GWJStimulator, Auditory, Evoked ResponseNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
GZODevice, Galvanic Skin Response MeasurementNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
JXEDevice, Nerve Conduction Velocity MeasurementNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162199000Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.2017-03-02GWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840067100646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067100646008400671006468400671006460840067100646

GMDN Terms#

Term, Definition table
TermDefinition
Neurophysiologic monitoring systemAn assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(509)735-6481applications@cadwell.com

Regulatory Flags#

DUNS number
098554157
Device count
1
DM exempt
true
Serial number
true

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