FDA device listing
Healthwise Lancets,SureComfort Lancets,SureComfort Lancing Pens,Up&Up Lancets,Up&Up Lancing Pens
FDA device listing 1867519303 · ALLISON MEDICAL, INC.
Key facts
| Proprietary names | Healthwise Lancets,SureComfort Lancets,SureComfort Lancing Pens,Up&Up Lancets,Up&Up Lancing Pens |
|---|---|
| Owner/operator | ALLISON MEDICAL, INC. |
| Owner/operator number | 9009434 |
| Product codes | FMK |
| Device names | FMK - Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4850 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ALLISON MEDICAL, INC. |
| Establishment registrations | 1722458 |
| FEI numbers | 1000138447 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database