| Primary Device ID | 03662724000307 |
| NIH Device Record Key | 65ad30ec-a6c1-42aa-b97b-3cfbaebfece6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | neuro|mate® - Adaptation for Fischer ZD frame |
| Version Model Number | Adaptation for frame |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662724000307 [Primary] |
| HAW | Neurological Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-03-04 |
| Device Publish Date | 2016-10-18 |
| 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. |
| 03662724000079 - neuromate tool guide | 2022-04-08 Long tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter of the central hole is ada |