FDA device listing
DUOLITH SD1 T-TOP
FDA device listing 1400958909 · STORZ MEDICAL AG
Key facts
| Proprietary names | DUOLITH SD1 T-TOP |
|---|---|
| Owner/operator | STORZ MEDICAL AG |
| Owner/operator number | 9028780 |
| Premarket submissions | K202112 |
| Product codes | PZL |
| Device names | PZL - Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4685 |
| Review panels | General & Plastic Surgery |
| Registered establishments | STORZ MEDICAL AG, STORZ MEDICAL AMERICA, INC. |
| Establishment registrations | 1061158, 9613347 |
| FEI numbers | 1000511585, 3002808188 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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