Primary Device ID | 00670082000603 |
NIH Device Record Key | d80bed43-3da4-4636-a41b-0cf5ecc42f90 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Modus IR |
Version Model Number | SYN-0990 |
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 | 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 | 00670082000603 [Primary] |
IZI | System, X-Ray, Angiographic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-10 |
Device Publish Date | 2024-04-02 |
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 |