| Primary Device ID | 00670082000122 |
| NIH Device Record Key | b9cf7704-3a4d-4e58-9f60-e0ab8e25612b |
| Commercial Distribution Discontinuation | 2017-08-16 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ImageDrive Pro |
| Version Model Number | 1.1 |
| Catalog Number | SYN-0627 |
| 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 | 00670082000122 [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 | 2017-08-16 |
| 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 |