| Primary Device ID | 05415334053045 |
| NIH Device Record Key | 13b437c0-4983-4b9a-bc14-9ea9c76bbc31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eonis 3D |
| Version Model Number | MDRC-8127 |
| Catalog Number | K9301153A2X |
| Company DUNS | 371618773 |
| Company Name | Barco NV |
| 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 |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com | |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com | |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com | |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com | |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com | |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com | |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com | |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com | |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com | |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com | |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com | |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com | |
| Phone | +1 866-302-7939 |
| service.medical.usa@barco.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415334053045 [Primary] |
| LMD | System, Digital Image Communications, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-09 |
| Device Publish Date | 2025-12-01 |
| 05415334050013 - Barco | 2025-12-09 MDSC-8532 NXF M2 |
| 05415334053045 - Eonis 3D | 2025-12-09MDRC-8127 SLIB |
| 05415334053045 - Eonis 3D | 2025-12-09 MDRC-8127 SLIB |
| 05415334060159 - Nio 5.8MP Gray | 2025-12-09 MDNG-6221 SPEF |
| 05415334054967 - Nio 5.8MP Color | 2025-08-19 MDNC-6121 SPEF |
| 05415334054974 - Nio 5.8MP Color | 2025-08-19 MDNC-6121 SNEF |
| 05415334054981 - Nio 5.8MP Gray | 2025-08-19 MDNG-6221 SPEF |
| 05415334054998 - Nio 5.8MP Gray | 2025-08-19 MDNG-6221 SNEF |
| 05415334058415 - Barco | 2025-08-13 Medical image management and processing SW |