UDI device identifier
Triad Combonation Unit Triad Combo,OTE,10A,Digital,RIC,Beige,Right
UDI device identifier 00089518000528 · GENERAL HEARING INSTRUMENT, INC.
Key facts
| Primary DI | 00089518000528 |
|---|---|
| Brand name | Triad Combonation Unit |
| Version or model | Triad Combo,OTE,10A,Digital,RIC,Beige,Right |
| Company | GENERAL HEARING INSTRUMENT, INC. |
| DUNS number | 131229197 |
| Product code | KLW |
| GMDN term | Air-conduction tinnitus masker, out-of-ear |
| Premarket submission | K974751 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 28, 2016 |
| Version date | Aug 5, 2022 |
| Description | The Triad Combination Unit is a programmable advanced digital signal processing system incorporating Tinnitus noise masking for patients that suffer from hearing loss, hyperacusis, and or 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: