| Primary Device ID | 00670082000566 |
| NIH Device Record Key | 457ccfaa-5be6-4230-92d8-a56fa8cb4b9b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Modus X |
| Version Model Number | SYN-0976 |
| Company DUNS | 203061833 |
| Company Name | Synaptive Medical Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 00670082000566 [Primary] |
| EPT | Microscope, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-14 |
| Device Publish Date | 2023-03-06 |
| 00670082000573 | Robotic Exoscope |
| 00670082000566 | Robotic Exoscope |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MODUS X 97882756 not registered Live/Pending |
SYNAPTIVE MEDICAL INC. 2023-04-11 |