| Primary Device ID | 05414904015667 |
| NIH Device Record Key | 36fb1df9-e5d1-40b8-bf14-73b5a683044c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DRYSTAR Axys |
| Version Model Number | 5367/100 |
| Catalog Number | EYZ4E |
| Company DUNS | 374444883 |
| Company Name | AGFA |
| 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 | 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(877)777-2432 |
| salesinfo@agfa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414904015667 [Primary] |
| LMC | Camera, multi format, radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-14 |
| Device Publish Date | 2016-09-01 |
| 05414904271124 - SE Suite | 2023-10-18 Software |
| 05414904208168 - NX 3.0 | 2023-07-26 |
| 05414904233320 - NX 4.0 | 2023-07-26 |
| 05414904281321 - DR 400 | 2023-03-31 |
| 05414904225066 - Mamoray HDR-C Plus | 2022-11-24 |
| 05414904231678 - Dentus M2 Comfort | 2022-11-24 |
| 05414904231692 - Dentus M2 Comfort | 2022-11-24 |
| 05414904231531 - Dentus Ortholux Register | 2022-11-14 |