| Primary Device ID | 05414904255131 |
| NIH Device Record Key | 8e1ddc6c-5366-438a-9a6b-41afcbac3140 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dentus Ortholux |
| Version Model Number | DENTUS ORTHOLUX 18x24 |
| Catalog Number | 39N7P |
| 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 |
| Width | 24 Centimeter |
| Length | 18 Centimeter |
| Width | 24 Centimeter |
| Length | 18 Centimeter |
| Width | 24 Centimeter |
| Length | 18 Centimeter |
| Width | 24 Centimeter |
| Length | 18 Centimeter |
| Width | 24 Centimeter |
| Length | 18 Centimeter |
| 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). Only open in darkroom. |
| 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). Only open in darkroom. |
| 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). Only open in darkroom. |
| 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). Only open in darkroom. |
| 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). Only open in darkroom. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414904255131 [Package] Contains: 05414904256015 Package: [5 Units] In Commercial Distribution |
| GS1 | 05414904255391 [Unit of Use] |
| GS1 | 05414904256015 [Primary] |
| 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 | 2022-11-08 |
| Device Publish Date | 2022-10-31 |
| 05414904255131 | DENTUS ORTHOLUX 18x24 |
| 05414904231616 | DENTUS ORTHOLUX 15X30 |
| 05414904231593 | DENTUS ORTHOLUX 20X25 |
| 05414904231630 | DENTUS ORTHOLUX 13X31 |