| Primary Device ID | 05415334028425 |
| NIH Device Record Key | 92666490-6a7f-4609-96a2-cce289f3f3ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nio Fusion 12MP |
| Version Model Number | MDNC-12130 |
| Catalog Number | K9301130A |
| 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 | 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 | 05415334028425 [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 | 2021-01-14 |
| Device Publish Date | 2021-01-06 |
| 05415334028425 | MDNC-12130 NC |
| 05415334044357 | MDNC-12130 |
| 05415334049734 | MDNC-12130 H NC |