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RENISHAW MAYFIELD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091088883009108888RENISHAW MAYFIELD1N2026-01-0131 rue Ampere Chassieu Rhone FR 69680

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
03662724000093neuro mate® - Registration tool-holder - The registration tool-holder (or ultrasound tool-holder) is used during registration in ultrasound Frameless mode. Delivered in a storage case.+33437238900xxx@xx.xx
03662724000116neuro mate® - CT Scanner Localizer - 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.+33437238900xxx@xx.xx
03662724000147neuro mate® - Temporary implant insert - A part of the fiducial fixation kit, indispensable for the ultrasound Frameless mode. It is screwed on the patient's skull during a surgical action.+33437238900xxx@xx.xx
03662724000154neuro mate® - Bone fixation pin Diameter 3,5mm - A part of the fiducial fixation kit, the pin allows to prevent the rotation of the temporary implant insert.+33437238900xxx@xx.xx
03662724000178neuro mate® - Long stop collar for drill - A part of the fiducial fixation kit, the long stop collar is fixed on the drill in order to limit the depth of the drill.+33437238900xxx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1732761973782716K181706neuromate Gen IIIHAW2018-07-26
1732761577191138K132755NEUROMATE FRAMELESS GEN IIHAW2014-04-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HAW22018-07-26

PMN#

GUDID#

neuro mate® frameless Gen II stereotactic system - neuro mate® is an image-guided, computer-controlled, 5-axis articulated arm. It is intended for use in an operating room to position and orientate as prescribed by the surgeon a guide into which the surgeon can manually insert standard stereotactic instruments. neuro mate® provides the surgeon with precise, reliable, and reproducible mechanical assistance in order to guide instruments during surgical interventions. neuro mate® could be considered as a motorised stereotactic frame controlled by interactive PC-based imaging software which provides three-dimensional images of the anatomical structures of the brain as well as the target points.The neuro mate® is a configurable medical device that is composed of a mobile support with or without a spacer, an arm, a planning trolley (with a planning station and a planning software), a remote control and cables.

RENISHAW MAYFIELD

2016-09-01