UDI device identifier
Simply Tranquil II Simply Tranquil II,10A,Digital,Pair
UDI device identifier 00089518000504 · GENERAL HEARING INSTRUMENT, INC.
Key facts
| Primary DI | 00089518000504 |
|---|---|
| Brand name | Simply Tranquil II |
| Version or model | Simply Tranquil II,10A,Digital,Pair |
| Company | GENERAL HEARING INSTRUMENT, INC. |
| DUNS number | 131229197 |
| Product code | KLW |
| GMDN term | Air-conduction tinnitus masker, in-the-ear |
| Premarket submission | K061459 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 28, 2016 |
| Version date | May 2, 2024 |
| Description | The Simply Tranquil II utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing in the canal design. Designed for Tinnitus assistance. Excellent to sleep with while wearing the device. |
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: