| Primary Device ID | 00889989087895 |
| NIH Device Record Key | 560e7d80-f380-41ff-be9c-b41178480833 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bite Orthotic Appliance |
| Version Model Number | 3000-0125 |
| Company DUNS | 158312728 |
| Company Name | ALLESEE AOA-PRO |
| Device Count | 1 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889989087895 [Primary] |
| KMY | POSITIONER, TOOTH, PREFORMED |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-13 |
| Device Publish Date | 2023-04-05 |
| 00889989088571 - Prezurv Plus | 2024-05-13 Prezurv Plus |
| 00889989081817 - Memotain | 2023-08-01 Memotain |
| 10889989087649 - Archwire Extender Accessory, Size .022, Cast Body, Pk of 10 | 2023-04-13 Archwire Extender Accessory, Size .022, Cast Body, Pk of 10 |
| 00889989087659 - Herbst Hanks Telescoping Accessories | 2023-04-13 Herbst Hanks Telescoping Accessories |
| 00889989087666 - Herbst Mini-Scope Accessories | 2023-04-13 Herbst Mini-Scope Accessories |
| 10889989087670 - Herbst Pistons, Pk/2 | 2023-04-13 Herbst Pistons, Pk/2 |
| 10889989087687 - Herbst Sleeves, set | 2023-04-13 Herbst Sleeves, set |
| 10889989087694 - 5.5mm Hex Screw, Pk/10 | 2023-04-13 5.5mm Hex Screw, Pk/10 |