FDA.reportPublic FDA data

Dorado KT Cart with Evox (120V)

Primary DI
00627825005289
Brand
Dorado KT Cart with Evox (120V)
Company
Laborie Medical Technologies Canada ULC
Model
Dorado KT with EVOX
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE
JXEDEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2
JXEDevice, Nerve Conduction Velocity MeasurementNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082614000EVOX ELECTRO DIAGNOSTIC DEVICELaborie Medical Technologies, Inc.2009-03-06GWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627825005289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627825005289006278250052896278250052890627825005289

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential graphic recording systemAn assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203383526
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10627825005958Urocap IV LightUCL10002016-09-21
10627825005965Urocap IV LightUCL10012016-09-21
00627825003599Urocap IVTRA8512016-09-21
00627825003629Urocap VTRA10022016-09-21
00627825005760Urocap IIITRA7092016-09-21
00627825005777Urocap IIITRA7112016-09-21
00627825005937Urocap IV LightUCL20002016-09-21
00627825005944Urocap IV LightUCL20012016-09-21
00627825000031Pump Tubing Infusion LineTUB5002016-09-21
00627825011013Probe, Manometry, Vaginal SensorPRB1132017-09-01
00627825011020Probe, Manometry, Anal SensorPRB1082017-09-01
00627825011037Tube for Anal Sensor, with 3-way StopcockPRB0782017-09-01
00627825011044Tube for Vaginal Sensor, with 3-way StopcockPRB0802017-09-01
00627825000109ITAITA2016-09-21
00627825008204Y-Piece9021P11642016-09-21
10627825007020Extension Set 29021P12832016-09-21
10627825007297Extension Line, 60 cm9021P63122016-09-21
10627825007310Extension Line, 1500mm9021P63322016-09-21
10627825007327Extension Line, 15cm9021P63512016-09-21
10627825007341Extension Line, 150cm Blue9021P63712016-09-21

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