| Primary Device ID | 00089518000351 |
| NIH Device Record Key | bd1d5165-a01b-4d9b-8452-00d2949c8307 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tranquil II OTE |
| Version Model Number | Tranquil II,OTE,10A,Digital,Beige,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 |
| 00089518000443 | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi |
| 00089518000436 | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi |
| 00089518000429 | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi |
| 00089518000412 | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi |
| 00089518000405 | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi |
| 00089518000399 | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi |
| 00089518000382 | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi |
| 00089518000375 | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi |
| 00089518000368 | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi |
| 00089518000351 | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi |
| 00089518000344 | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi |
| 00089518000337 | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi |