neuro mate® - Registration frame

Primary DI
03662724000109
Brand
neuro mate® - Registration frame
Company
RENISHAW MAYFIELD
Model
Tool-holder
Catalog number
001.0011
Device description
The registration frame (or microphone frame) is attached to the temporary implant insert at the start of surgery in order to map the patient with the neuro mate® in the ultrasound Frameless mode. Delivered in a storage case.
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
03662724000109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662724000109036627240001093662724000109

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
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
03662724000482neuromate - neuroinspire softwareneuroinspire SW Atlas Module001.01232024-03-12
03662724000758neuromate planning station hardwarePC Cart (Workstation Cart)043.00152024-03-12
03662724000031neuromate tool-holderneuro mate Standard tool-holder2016-10-18

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