| Primary Device ID | 06945936702403 |
| NIH Device Record Key | db3a8e4c-3e1a-432c-b80a-4337a1e33e74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMH |
| Version Model Number | Forte 800 |
| Company DUNS | 528181200 |
| Company Name | Xiamen New Sound Technology Co., Ltd. |
| 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 | 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 |