xx.xxNeuromate Gen III
Renishaw Mayfield Sarl
RENISHAW MAYFIELD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009108888 | 3009108888 | RENISHAW MAYFIELD | 1 | N | 2026-01-01 | 31 rue Ampere Chassieu Rhone FR 69680 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03662724000093 | neuro 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. | +33437238900 | xxx@xx.xx |
| 03662724000116 | neuro 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. | +33437238900 | xxx@xx.xx |
| 03662724000147 | neuro 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. | +33437238900 | xxx@xx.xx |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 173276 | 1973782716 | K181706 | neuromate Gen III | HAW | 2018-07-26 |
| 173276 | 1577191138 | K132755 | NEUROMATE FRAMELESS GEN II | HAW | 2014-04-29 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HAW | 2 | 2018-07-26 |
PMN#
Neuromate Gen III
Renishaw Mayfield Sarl
NEUROMATE FRAMELESS GEN II
RENISHAW MAYFIELD SARL
GUDID#
neuromate - Tool guide - OD15 - Microdrive AlphaOmega
2026-07-14
neuromate - Tool guide - OD15 - Microdrive FHC stardrive - ZD Leibinger
2026-07-14
neuromate - frame attachment - Integra CRW frame attachment - 15' angle
2026-07-14
neuro 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.
2016-10-18
neuro 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.
2016-10-18
neuro 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.
2016-10-18
neuro mate® - MRI Localizer - The imaging localizer is attached to the temporary implant insert when the patient goes into the MRI scanner for use in the ultrasound Frameless mode. Delivered in a storage case.
2016-10-18
neuro mate® - Fiducial fixation Kit - The kit is only used for the ultrasound Frameless registration. The fiducial fixation kit comprises a temporary implant insert, a screwdriverfor the temporary implant insert, four pins, a screwdriver for the pins, a drill, a stop collar, a screwdriver for the stop collar and a sterilization container.
2018-06-18
neuro 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.
2016-10-18
neuro 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.
2016-10-18
neuro mate® - Screwdriver for the temporary implant insert - A part of the fiducial fixation kit, the screwdriver is used for screwing the temporary implant insert in the patient's skull.
2016-10-18
neuro mate® - Bone fixation pin screwdriver - A part of the fiducial fixation kit, the screwdriver is used for screwing the pins through the temporary implant insert in the patient's skull.
2016-10-18
neuro mate® - Frameless Head-holder kit - The head-holder kit consists of a half-ring, six pins, a clip for fixing the half-ring onto the head-holder attachment. The kit is fixed on the base of the neuro mate®.
2016-10-18
neuro mate® - Frameless Head-holder ring - A part of the Frameless Head-holder kit, the patient's head is immobilized in the head-holder ring before doing imaging.
2016-10-18
neuro mate® - Frameless Head-holder - Clip - A part of the Frameless Head-holder kit, the clip fixes the Head-holder ring onto the head-holder attachment.
2016-10-18
neuro mate® - Frameless Head-holder support - This support is used to fix the Frameless head-holder on the neuro mate® system thanks to two screws.
2016-10-18
neuro mate® - Adaptation for Fischer ZD frame - This support is used to fix a Fischer ZD frame on the neuro mate® in Framebased mode.
2016-10-18
neuromate neuroinspire software - neuroinspire planning software
2024-03-12
neuromate planning station hardware - neuroinspire PC - Desktop US
2024-03-12
Neuromate Planning Station Hardware - neuroinspire PC - Laptop US
2024-03-12
neuromate - neuroinspire software - neuroinspire SW Atlas Module
2024-03-12
neuromate planning station hardware - PC Cart (Workstation Cart)
2024-03-12
neuromate tool-holder - The standard tool-holder is universal and features a guide bushing into which standard neurosurgical instruments may be inserted such as drills, tube-guides, biopsy instruments and catheters, etc.It can be sold and delivered with a sterilization container.
2016-10-18
neuromate tool guide - Tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter of the central hole is adapted.
2016-10-18
neuromate tool guide - Long tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter of the central hole is adapted.
2016-10-18
neuromate tool guide - Tool guide OD15 - Microdrive FHC microtargeting
2016-12-22
neuromate tool guide - Tool guide OD15 - Microdrive FHC stardrive - Lekse
2016-12-22
neuromate tool guide - Tool guide OD15 - Standard guide with tool locking
2017-10-05
neuromate tool guide - Tool guide OD15 - Monteris laser Ablation Kit
2016-10-18
NMControl - v.1.6.
2019-06-19
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.
2016-09-01
neuro mate® - Tool-holder fixation screw - Screw used for the fixation of the tool-holder on the neuro mate® system.
2016-10-18
neuro mate® - Tool-holder locking screw - Tightening screw used to lock the tool adaptor into the neuro mate tool-holder.
2016-10-18
neuro mate® - Laser tool-holder - The laser tool-holder is used to check the system's precision before beginning surgery. It is also used to indicate trajectory entry points on the skull's surface.Delivered in a storage case.
2016-10-18
neuro mate® - Registration frame - 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.
2016-10-18
neuro mate® - Bone fixation drill 3mm - The drill is used to create a hole in the patient's skull to screw the temporary implant insert.
2016-10-18
neuro mate® - Adaptation for CRW Integra frame - This support is used to fix a CRW frame on the neuro mate® in Framebased mode.
2016-10-18
neuro mate® - Adaptation for Leksell Model G Elekta frame - This support is used to fix a Leksell Model G Elekta frame on the neuro mate® in Framebased mode.
2016-10-18
neuro mate® Gen III stereotactic system - neuro mate v1.5
2018-05-15