| Primary Device ID | 05902596226060 |
| NIH Device Record Key | 023b8eeb-7bf6-4398-9731-c3303c57a72d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inoris Medical Sp. z o.o. |
| Version Model Number | IM-10 Clip-on Biteguard |
| Company DUNS | 522725233 |
| Company Name | INORIS MEDICAL SP Z O O |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |