| Primary Device ID | 03662724000147 |
| NIH Device Record Key | d8cd8b1c-cff8-48cc-a841-1fceb67e9b11 |
| Commercial Distribution Discontinuation | 2018-04-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | neuro|mate® - Temporary implant insert |
| Version Model Number | Fiducial fixation kit |
| Catalog Number | 003.0064 |
| Company DUNS | 277433335 |
| Company Name | RENISHAW MAYFIELD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +33437238900 |
| xxx@xx.xx | |
| Phone | +33437238900 |
| xxx@xx.xx | |
| Phone | +33437238900 |
| xxx@xx.xx | |
| Phone | +33437238900 |
| xxx@xx.xx | |
| Phone | +33437238900 |
| xxx@xx.xx | |
| Phone | +33437238900 |
| xxx@xx.xx | |
| Phone | +33437238900 |
| xxx@xx.xx | |
| Phone | +33437238900 |
| xxx@xx.xx | |
| Phone | +33437238900 |
| xxx@xx.xx | |
| Phone | +33437238900 |
| xxx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662724000147 [Primary] |
| HAW | Neurological Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03662724000147]
Moist Heat or Steam Sterilization
[03662724000147]
Moist Heat or Steam Sterilization
[03662724000147]
Moist Heat or Steam Sterilization
[03662724000147]
Moist Heat or Steam Sterilization
[03662724000147]
Moist Heat or Steam Sterilization
[03662724000147]
Moist Heat or Steam Sterilization
[03662724000147]
Moist Heat or Steam Sterilization
[03662724000147]
Moist Heat or Steam Sterilization
[03662724000147]
Moist Heat or Steam Sterilization
[03662724000147]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2025-06-16 |
| Device Publish Date | 2016-10-18 |
| 03662724000147 - neuro|mate® - Temporary implant insert | 2025-06-16A part of the fiducial fixation kit, indispensable for the ultrasound Frameless mode. It is screwed on the patient's skull during a surgical action. |
| 03662724000147 - neuro|mate® - Temporary implant insert | 2025-06-16 A part of the fiducial fixation kit, indispensable for the ultrasound Frameless mode. It is screwed on the patient's skull durin |
| 03662724000390 - neuromate neuroinspire software | 2024-03-20 |
| 03662724000444 - neuromate planning station hardware | 2024-03-20 |
| 03662724000451 - Neuromate Planning Station Hardware | 2024-03-20 |
| 03662724000482 - neuromate - neuroinspire software | 2024-03-20 |
| 03662724000758 - neuromate planning station hardware | 2024-03-20 |
| 03662724000031 - neuromate tool-holder | 2022-04-08 The standard tool-holder is universal and features a guide bushing into which standard neurosurgical instruments may be inserted |
| 03662724000055 - neuromate tool guide | 2022-04-08 Tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter of the central hole is adapted. |