| Primary Device ID | 05415334000124 |
| NIH Device Record Key | 83fc5f81-be95-4bd6-b178-d971342b81bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coronis 5MP Mammo |
| Version Model Number | MDMG-5121 |
| 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 | 05415334000124 [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 | 3 |
| Public Version Date | 2018-12-20 |
| Device Publish Date | 2016-06-30 |
| 05415334001589 | MDMG-5121 |
| 05415334001503 | MDMG-5121 |
| 05415334000124 | MDMG-5121 |