FDA.reportPublic FDA data

neuro mate® - Tool-holder fixation screw

Primary DI
03662724000048
Brand
neuro mate® - Tool-holder fixation screw
Company
RENISHAW MAYFIELD
Model
Screw
Catalog number
005.0743
Device description
Screw used for the fixation of the tool-holder on the neuro mate® system.
Published
2016-10-18
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
03662724000048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662724000048036627240000483662724000048

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

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