FDA.reportPublic FDA data

neuro mate® - MRI Localizer

Primary DI
03662724000123
Brand
neuro mate® - MRI Localizer
Company
RENISHAW MAYFIELD
Model
Localizer
Catalog number
001.0016
Device description
The imaging localizer is attached to the temporary implant insert when the patient goes into the MRI scanner for use in the ultrasound Frameless mode. Delivered in a storage case.
Published
2016-10-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662724000123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662724000123036627240001233662724000123

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Regulatory Flags#

DUNS number
277433335
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662724000611neuromate - Tool guideOD15 - Microdrive AlphaOmega003.01632026-07-14
03662724000642neuromate - Tool guideOD15 - Microdrive FHC stardrive - ZD Leibinger005.09072026-07-14
03662724000727neuromate - frame attachmentIntegra CRW frame attachment - 15' angle003.01432026-07-14
03662724000147neuro mate® - Temporary implant insertFiducial fixation kit003.00642016-10-18
03662724000093neuro mate® - Registration tool-holderTool-holder001.01062016-10-18
03662724000116neuro mate® - CT Scanner LocalizerLocalizer001.00102016-10-18
03662724000130neuro mate® - Fiducial fixation KitFiducial fixation kit001.00172018-06-18
03662724000154neuro mate® - Bone fixation pin Diameter 3,5mmFiducial fixation kit005.03352016-10-18
03662724000178neuro mate® - Long stop collar for drillFiducial fixation kit005.06612016-10-18
03662724000185neuro mate® - Screwdriver for the temporary implant insertFiducial fixation kit005.03902016-10-18
03662724000192neuro mate® - Bone fixation pin screwdriverFiducial fixation kit005.03942016-10-18
03662724000215neuro mate® - Frameless Head-holder kitFrameless Head-holder kit001.00302016-10-18
03662724000222neuro mate® - Frameless Head-holder ringFrameless Head-holder kit005.03952016-10-18
03662724000239neuro mate® - Frameless Head-holder - ClipFrameles head-holder kit004.00192016-10-18
03662724000277neuro mate® - Frameless Head-holder supportHead-holder support001.00132016-10-18
03662724000307neuro mate® - Adaptation for Fischer ZD frameAdaptation for frame2016-10-18
03662724000390neuromate neuroinspire softwareneuroinspire planning software001.01422024-03-12
03662724000444neuromate planning station hardwareneuroinspire PC - Desktop US001.01192024-03-12
03662724000451Neuromate Planning Station Hardwareneuroinspire PC - Laptop US001.01302024-03-12
03662724000482neuromate - neuroinspire softwareneuroinspire SW Atlas Module001.01232024-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503829Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503836Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503843Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
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00889024714113PLANNING STATION - USAMEDTECHHAW2026-09-28
00889024704213PLANNING STATION - USAMEDTECHHAW2026-02-23
04056481146702Curve NavigationBrainlab SEHAW2025-10-13
00889024679559ALLEN WRENCH 8MMMEDTECHHAW2025-07-15
00887868539978SEEG DRILL ADAPTOR 2.70MMMEDTECHHAW2025-06-24
00889024663282PLANNING STATION - ROSA ONE - USAMEDTECHHAW2024-02-20
00887868585951ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2023-10-30
03760244031129Trnsnsl Endscp Ovoid Ø6.18mm HolderMEDTECHHAW2023-10-27
04056481144500Curve Navigation 17700Brainlab SEHAW2023-05-22
03760244034793ROSA ONE SURGICAL ASSISTANT (US)MEDTECHHAW2022-06-20
03760244034922PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244035127PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244034625SEEG DRILL ADAPTOR Ø2.5MMMEDTECHHAW2022-02-18
03760244034632SEEG DRILL ADAPTOR Ø2.15MMMEDTECHHAW2022-02-18
03760244034649SEEG DRILL ADAPTOR Ø2.45MMMEDTECHHAW2022-02-18
03760244034656SEEG DRILL ADAPTOR Ø2.55MMMEDTECHHAW2022-02-18
03760244034663SEEG DRILL ADAPTOR Ø3.2MMMEDTECHHAW2022-02-18
03760244032195Optical distance sensorMEDTECHHAW2021-06-15
03760244034304ROBOT ROSA ONE (USA)MEDTECHHAW2021-05-31
03760244034403PLANNING STATION Rosa One -USAMEDTECHHAW2021-05-31
04056481143503Kick 2 Navigation StationBrainlab SEHAW2021-05-31
03760244030962CRW frame adaptorMEDTECHHAW2020-11-20
03760244031914LEKSELL FRAME REGISTRATION PLATESMEDTECHHAW2020-10-20