UDI device identifier
LEADER, pen needles 31G x 8 mm
UDI device identifier 00096295138764 · HTL STREFA S A
Key facts
| Primary DI | 00096295138764 |
|---|---|
| Brand name | LEADER, pen needles |
| Version or model | 31G x 8 mm |
| Catalog number | 8470 |
| Company | HTL STREFA S A |
| DUNS number | 422528088 |
| Product code | FMI |
| GMDN term | Autoinjector needle |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Dec 19, 2019 |
| Version date | Aug 16, 2021 |
| Description | Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous injection of drugs. |
At a glance
- None MAUDE reports citing this UDI
- No 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: