| Primary Device ID | 00670082000030 |
| NIH Device Record Key | 962e7d8a-14f0-45a8-99c1-b48d6b67013a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tracking Array for Brainpath |
| Version Model Number | SYN-0015 |
| Company DUNS | 203061833 |
| Company Name | Synaptive Medical Inc |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00670082000030 [Primary] |
| GS1 | 10670082000037 [Package] Package: [10 Units] In Commercial Distribution |
| HAW | Neurological Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 00670082000603 - Modus IR | 2024-04-10 Surgical Exoscope Fluorescence Filter |
| 10670082000495 - Evry | 2023-10-24 |
| 00670082000511 - Modus Plan | 2023-10-18 |
| 00670082000566 - Modus X | 2023-03-14 Robotic Exoscope |
| 00670082000573 - Modus X | 2023-03-14 Robotic Exoscope |
| 00670082000580 - Modus Blue | 2023-03-14 Robotic Exoscope Fluorescence Filter |
| 00670082000085 - BrightMatter Plan | 2019-08-16 |
| 00670082000160 - BrightMatter Plan | 2019-08-16 |