| Primary Device ID | 05415334002050 |
| NIH Device Record Key | adf3d28a-b71e-4244-8bf1-d72594580eba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intuitive Workflow Tools |
| Version Model Number | 2.X.X.X |
| Catalog Number | K9308260 |
| Company DUNS | 371618773 |
| Company Name | Barco NV |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 | 05415334002050 [Primary] |
| PGY | Display, diagnostic radiology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-31 |
| Device Publish Date | 2020-07-23 |
| 05415334049895 - Coronis Fusion 4MP | 2025-04-24 MDCC-4430 |
| 05415334049901 - Coronis Fusion 4MP | 2025-04-24 MDCC-4430 NC |
| 05415334049925 - Coronis Fusion 6MP | 2025-04-24 MDCC-6530 |
| 05415334049932 - Coronis Fusion 6MP | 2025-04-24 MDCC-6530 NC |
| 05415334053717 - Barco | 2025-04-22 MDRC-2422 SNEW |
| 05415334053724 - Barco | 2025-04-22 MDRC-2422 SPEW |
| 05415334053731 - Barco | 2025-04-22 MDRC-2422 SNIB |
| 05415334054059 - Barco | 2025-04-22 MDRC-2422 STIB |