UDI device identifier
Biotene Oral Balance Gel
UDI device identifier 00048582512016 · Haleon US Holdings LLC
Key facts
| Primary DI | 00048582512016 |
|---|---|
| Brand name | Biotene |
| Version or model | Oral Balance Gel |
| Company | Haleon US Holdings LLC |
| DUNS number | 079944263 |
| Product code | LFD |
| GMDN term | Artificial saliva |
| Premarket submission | K061331 |
| Device class | Unclassified |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Apr 14, 2023 |
| Version date | Feb 27, 2024 |
| Description | Biotene Oral Balance Gel 1x42g |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 10–99 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: