UDI device identifier
Tranquil II OTE Tranquil II,OTE,10A,Digital,Black,Left
UDI device identifier 00089518000399 · GENERAL HEARING INSTRUMENT, INC.
Key facts
| Primary DI | 00089518000399 |
|---|---|
| Brand name | Tranquil II OTE |
| Version or model | Tranquil II,OTE,10A,Digital,Black,Left |
| Company | GENERAL HEARING INSTRUMENT, INC. |
| DUNS number | 131229197 |
| Product code | KLW |
| GMDN term | Air-conduction tinnitus masker, out-of-ear |
| Premarket submission | K061459 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 28, 2016 |
| Version date | Aug 5, 2022 |
| Description | The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1,000+ GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: