| Primary Device ID | 00190707099367 |
| NIH Device Record Key | 9c4f15e7-f1b0-45e8-ba77-6a5345c9adc9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DuraLock® PLUS Impression Trays |
| Version Model Number | 640-051 |
| Company DUNS | 062165188 |
| Company Name | Ortho Organizers, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190707099367 [Primary] |
| EHY | TRAY, IMPRESSION, PREFORMED |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-19 |
| Device Publish Date | 2022-01-06 |
| 00190707099411 | DuraLock® PLUS Impression Tray - Size: 6 Extra Large, PURPLE Lower |
| 00190707099404 | DuraLock® PLUS Impression Tray - Size: 5 Large, YELLOW Lower |
| 00190707099398 | DuraLock® PLUS Impression Tray - Size: 4 Medium, GREEN Lower |
| 00190707099381 | DuraLock® PLUS Impression Tray - Size: 3 Small, BLUE Lower |
| 00190707099374 | DuraLock® PLUS Impression Tray - Size: 2 Extra Small, ORANGE Lower |
| 00190707099367 | DuraLock® PLUS Impression Tray - Size: 1 Pedo, RED Lower |
| 00190707099350 | DuraLock® PLUS Impression Tray - Size: 6 Extra Large, PURPLE Upper |
| 00190707099343 | DuraLock® PLUS Impression Tray - Size: 5 Large, YELLOW Upper |
| 00190707099336 | DuraLock® PLUS Impression Tray - Size: 4 Medium, GREEN Upper |
| 00190707099329 | DuraLock® PLUS Impression Tray - Size: 3 Small, BLUE Upper |
| 00190707099312 | DuraLock® PLUS Impression Tray - Size: 2 Extra Small, ORANGE Upper |
| 00190707099305 | DuraLock® PLUS Impression Tray - Size: 1 Pedo, RED Upper |
| 00190707099299 | DuraLock® PLUS Impression Trays Assortment |