FDA.reportPublic FDA data

neuromate tool guide

Primary DI
03662724000314
Brand
neuromate tool guide
Company
RENISHAW MAYFIELD
Model
Tool guide OD15 - Microdrive FHC microtargeting
Catalog number
005.0804
Published
2016-12-22
Public version status
Update
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132755000NEUROMATE FRAMELESS GEN IIRenishaw Mayfield Sarl2014-04-29HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662724000314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662724000314036627240003143662724000314

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
277433335
Device count
1
Lot or batch
true
Sterilization required before use
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
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

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
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
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