FDA device listing
Prodigy Adjustable Depth Lancing Device
FDA device listing 1776058302 · OK BIOTECH CO., LTD.
Key facts
| Proprietary names | Prodigy Adjustable Depth Lancing Device |
|---|---|
| Owner/operator | OK BIOTECH CO., LTD. |
| Owner/operator number | 9090860 |
| 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 | OK BIOTECH CO., LTD. |
| Establishment registrations | 3005862821 |
| FEI numbers | 3005862821 |
| Establishment operations | Foreign Exporter |
| 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