| Primary Device ID | 00670082000115 |
| NIH Device Record Key | dfd8d29b-57c1-45a8-be81-97d9b4cdb5e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ImageDrive Clinical |
| Version Model Number | 1.1 |
| Catalog Number | SYN-0578 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00670082000115 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-05-23 |
| Device Publish Date | 2016-09-24 |
| 00670082000252 - Multi-Tool Calibration Device | 2025-06-23 |
| 00670082000269 - Short Pointer | 2025-06-23 |
| 00670082000351 - Sterilizable Storage Tray | 2025-06-23 |
| 00670082000467 - Modus V | 2025-06-23 Robotic Digital Microscope |
| 00670082000474 - Modus V | 2025-06-23 Robotic Digital Microscope |
| 00670082000504 - Modus Nav Software | 2025-06-23 |
| 00670082000528 - Modus Nav Operator Cart | 2025-06-23 |
| 00670082000535 - Long Pointer | 2025-06-23 |