| Primary Device ID | 05902596226367 |
| NIH Device Record Key | 506c679b-e72a-4e46-b7d3-6780adc1bd06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INORIS MEDICAL |
| Version Model Number | IM-60 Adult Biteguard |
| Catalog Number | IM-60 |
| Company DUNS | 522725233 |
| Company Name | INORIS MEDICAL SP Z O O |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |