UDI device identifier
Assure® Lance Safety Lancets 980028
UDI device identifier 00015482980085 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482980085 |
|---|---|
| Brand name | Assure® Lance Safety Lancets |
| Version or model | 980028 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | FMK |
| GMDN term | Manual blood lancing device, single-use |
| Premarket submission | K222084 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Mar 27, 2020 |
| Version date | Aug 24, 2026 |
| Description | Assure Lance Safety Lancets 28g 10's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. |
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: