FDA.reportPublic FDA data

neuro mate® - CT Scanner Localizer

Primary DI
03662724000116
Brand
neuro mate® - CT Scanner Localizer
Company
RENISHAW MAYFIELD
Model
Localizer
Catalog number
001.0010
Device description
The imaging localizer is attached to the temporary implant insert when the patient goes into the CT 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

Contact Domains#

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
03662724000116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662724000116036627240001163662724000116

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.

Contacts#

Phone, Email table
PhoneEmail
+33437238900xxx@xx.xx

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
03662724000123neuro mate® - MRI LocalizerLocalizer001.00162016-10-18
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

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Primary DI, Brand, Company table
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04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693127Tag Support ArmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878694001Instrument Registration Platform CoverBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695022Instrument Holder SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695046Instrument Adaptor (3 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695060Instrument Adaptor (4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695084Instrument Adaptor (5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695107Instrument Adaptor (8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695121SEEG AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695145Catheter AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695169Thumb Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695183Set Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695206Pin Screw of Instrument AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695220Catheter Adaptor_3.5mmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695244Instrument Adaptor (1.8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695268Instrument Adaptor (2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695282Instrument Adaptor (2.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695305Instrument Adaptor (2.5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695329Instrument Adaptor (2.8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695343Instrument Adator (3.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695367Instrument Adaptor (3.5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25