neuro mate® frameless Gen II stereotactic system
- Primary DI
- 03662724000024
- Brand
- neuro mate® frameless Gen II stereotactic system
- Company
- RENISHAW MAYFIELD
- Model
- neuro mate v1.5
- Device description
- 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.
- Published
- 2016-09-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| HAW | Neurological Stereotaxic Instrument |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K132755 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 03662724000024 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 03662724000024 | 03662724000024 | 3662724000024 |
GMDN Terms#
| Term | Definition |
|---|---|
| Neurological stereotactic surgery system | An 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 | |
|---|---|
| +33437238900 | xxx@xx.xx |
Regulatory Flags#
- DUNS number
- 277433335
- Device count
- 1
- Serial number
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 03662724000611 | neuromate - Tool guide | OD15 - Microdrive AlphaOmega | 003.0163 | 2026-07-14 |
| 03662724000642 | neuromate - Tool guide | OD15 - Microdrive FHC stardrive - ZD Leibinger | 005.0907 | 2026-07-14 |
| 03662724000727 | neuromate - frame attachment | Integra CRW frame attachment - 15' angle | 003.0143 | 2026-07-14 |
| 03662724000147 | neuro mate® - Temporary implant insert | Fiducial fixation kit | 003.0064 | 2016-10-18 |
| 03662724000093 | neuro mate® - Registration tool-holder | Tool-holder | 001.0106 | 2016-10-18 |
| 03662724000116 | neuro mate® - CT Scanner Localizer | Localizer | 001.0010 | 2016-10-18 |
| 03662724000123 | neuro mate® - MRI Localizer | Localizer | 001.0016 | 2016-10-18 |
| 03662724000130 | neuro mate® - Fiducial fixation Kit | Fiducial fixation kit | 001.0017 | 2018-06-18 |
| 03662724000154 | neuro mate® - Bone fixation pin Diameter 3,5mm | Fiducial fixation kit | 005.0335 | 2016-10-18 |
| 03662724000178 | neuro mate® - Long stop collar for drill | Fiducial fixation kit | 005.0661 | 2016-10-18 |
| 03662724000185 | neuro mate® - Screwdriver for the temporary implant insert | Fiducial fixation kit | 005.0390 | 2016-10-18 |
| 03662724000192 | neuro mate® - Bone fixation pin screwdriver | Fiducial fixation kit | 005.0394 | 2016-10-18 |
| 03662724000215 | neuro mate® - Frameless Head-holder kit | Frameless Head-holder kit | 001.0030 | 2016-10-18 |
| 03662724000222 | neuro mate® - Frameless Head-holder ring | Frameless Head-holder kit | 005.0395 | 2016-10-18 |
| 03662724000239 | neuro mate® - Frameless Head-holder - Clip | Frameles head-holder kit | 004.0019 | 2016-10-18 |
| 03662724000277 | neuro mate® - Frameless Head-holder support | Head-holder support | 001.0013 | 2016-10-18 |
| 03662724000307 | neuro mate® - Adaptation for Fischer ZD frame | Adaptation for frame | 2016-10-18 | |
| 03662724000390 | neuromate neuroinspire software | neuroinspire planning software | 001.0142 | 2024-03-12 |
| 03662724000444 | neuromate planning station hardware | neuroinspire PC - Desktop US | 001.0119 | 2024-03-12 |
| 03662724000451 | Neuromate Planning Station Hardware | neuroinspire PC - Laptop US | 001.0130 | 2024-03-12 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| G076A900687A0 | Localite TMS Navigator TS | LOCALITE GmbH | HAW | 2026-08-03 |
| 04719878691024 | Nao Trac S | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878691208 | Foot Controller | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878691246 | Display Screen | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878691307 | USB Mouse | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878691420 | Power Supply Cord | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878691468 | Power Supply Cord (US) 5m | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878692021 | Surgical Equipment Drape Packs | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878693004 | Reference Stylus | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878693042 | Tag S | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878693127 | Tag Support Arm | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878694001 | Instrument Registration Platform Cover | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695022 | Instrument Holder S | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695046 | Instrument Adaptor (3 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695060 | Instrument Adaptor (4 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695084 | Instrument Adaptor (5 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695107 | Instrument Adaptor (8 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695121 | SEEG Adaptor | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695145 | Catheter Adaptor | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695169 | Thumb Screw of Instrument Holder | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695183 | Set Screw of Instrument Holder | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695206 | Pin Screw of Instrument Adaptor | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695220 | Catheter Adaptor_3.5mm | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695244 | Instrument Adaptor (1.8 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695268 | Instrument Adaptor (2 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695282 | Instrument Adaptor (2.2 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695305 | Instrument Adaptor (2.5 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695329 | Instrument Adaptor (2.8 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695343 | Instrument Adator (3.2 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |
| 04719878695367 | Instrument Adaptor (3.5 mm) | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 2026-07-25 |