| Primary Device ID | 00810002220005 |
| NIH Device Record Key | af7b9c27-6c87-4f76-998e-25d911a2e33b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Luco Hybrid Sleep appliance |
| Version Model Number | 3014680794 |
| Company DUNS | 016649253 |
| Company Name | JOHN'S DENTAL LABORATORY INC |
| 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 | true |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |