| Primary Device ID | 05414904224786 |
| NIH Device Record Key | 76827500-77ba-4846-b510-546ab1cab6cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DM2 B |
| Version Model Number | DM 2 B 35x43 |
| Catalog Number | EP1ND |
| Company DUNS | 374444883 |
| Company Name | AGFA |
| Device Count | 100 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | |
| Phone | +1(877)777-2432 |
| salesinfo@agfa.com | |
| Phone | +1(877)777-2432 |
| salesinfo@agfa.com | |
| Phone | +1(877)777-2432 |
| salesinfo@agfa.com | |
| Phone | +1(877)777-2432 |
| salesinfo@agfa.com | |
| Phone | +1(877)777-2432 |
| salesinfo@agfa.com | |
| Phone | +1(877)777-2432 |
| salesinfo@agfa.com | |
| Phone | +1(877)777-2432 |
| salesinfo@agfa.com | |
| Phone | +1(877)777-2432 |
| salesinfo@agfa.com | |
| Phone | +1(877)777-2432 |
| salesinfo@agfa.com |
| Width | 43 Centimeter |
| Length | 35 Centimeter |
| Width | 43 Centimeter |
| Length | 35 Centimeter |
| Width | 43 Centimeter |
| Length | 35 Centimeter |
| Width | 43 Centimeter |
| Length | 35 Centimeter |
| Width | 43 Centimeter |
| Length | 35 Centimeter |
| Width | 43 Centimeter |
| Length | 35 Centimeter |
| Width | 43 Centimeter |
| Length | 35 Centimeter |
| Width | 43 Centimeter |
| Length | 35 Centimeter |
| Width | 43 Centimeter |
| Length | 35 Centimeter |
| Width | 43 Centimeter |
| Length | 35 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). |
| Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). |
| Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). |
| Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). |
| Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). |
| Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). |
| Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). |
| Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). |
| Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). |
| Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). |
| Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414904005026 [Primary] |
| GS1 | 05414904224779 [Unit of Use] |
| GS1 | 05414904224786 [Package] Contains: 05414904005026 Package: [5 Units] In Commercial Distribution |
| IWZ | Film, radiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-14 |
| Device Publish Date | 2022-11-04 |
| 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 |