| Primary Device ID | 00089518000504 |
| NIH Device Record Key | 03da43ae-2244-4481-9aea-447de2d4308d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simply Tranquil II |
| Version Model Number | Simply Tranquil II,10A,Digital,Pair |
| Company DUNS | 131229197 |
| Company Name | GENERAL HEARING INSTRUMENT, INC. |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |