| Primary Device ID | J011150501300 |
| NIH Device Record Key | 86822894-a9ee-40bc-9aa0-20f11554e774 |
| Commercial Distribution Discontinuation | 2020-08-27 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Orthalgenat® |
| Version Model Number | 150-501-30 |
| Company DUNS | 315427286 |
| Company Name | DENTAURUM GmbH & Co.KG |
| 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 | 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| Special Storage Condition, Specify | Between 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use. |
| J011150520300 | Orthalgenat® Duo, Impression material, berry / 20 x 1 kg |
| J011150509300 | Orthalgenat® Duo, Impression material, berry / 9 x 1 kg |
| J011150501300 | Orthalgenat® Duo, Impression material, berry / 1 kg |
| J011150520200 | Orthalgenat® Duo, Impression material, mint |
| J011150509200 | Orthalgenat® Duo, Impression material, mint |
| J011150501200 | Orthalgenat® Duo, Impression material, mint |