UDI device identifier
Assure® ID Safety Pen Needle 8mm x 30g 100's 278130
UDI device identifier 00015482278304 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482278304 |
|---|---|
| Brand name | Assure® ID Safety Pen Needle 8mm x 30g 100's |
| Version or model | 278130 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | FMI |
| GMDN term | Autoinjector needle |
| Premarket submission | K161950 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Mar 8, 2018 |
| Version date | Aug 24, 2026 |
| Description | Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. |
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: