FDA device listing
Cardiovascular Surgical Instruments Tray - DeRoyal
FDA device listing 2067941185 · DEROYAL INDUSTRIES, INC.
Key facts
| Proprietary names | Cardiovascular Surgical Instruments Tray - DeRoyal |
|---|---|
| Owner/operator | DEROYAL INDUSTRIES, INC. |
| Owner/operator number | 1044833 |
| Product codes | OFA |
| Device names | OFA - Cardiovascular Surgical Instruments Tray |
| Device class | Class I |
| Classification regulations (21 CFR) | 870.4500 |
| Review panels | Cardiovascular |
| Registered establishments | DeRoyal Industries, Inc., DEROYAL INDUSTRIES, INC. |
| Establishment registrations | 1043214, 1054241, 1055236, 1057404, 2320762 |
| FEI numbers | 1043214, 1000112877, 1000112968, 1000208576, 3003040625 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer, Contract Sterilizer, Repackager/Relabeler |
| 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