FDA device listing
DynaBunion Full Custom Non-Sterile Case,DynaForce Staple Instruments Tray,MiniBunion Instruments Tray
FDA device listing 1194003285 · Micropulse
Key facts
| Proprietary names | DynaBunion Full Custom Non-Sterile Case,DynaForce Staple Instruments Tray,MiniBunion Instruments Tray |
|---|---|
| Owner/operator | Micropulse |
| Owner/operator number | 10042100 |
| Product codes | KCT |
| Device names | KCT - Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6850 |
| Review panels | General Hospital |
| Registered establishments | MICROPULSE INC |
| Establishment registrations | 1834379 |
| FEI numbers | 1000306303 |
| Establishment operations | Contract Manufacturer |
| 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