FDA device listing
Dressing, Wound, Drug - DeRoyal
FDA device listing 1481070373 · DEROYAL INDUSTRIES, INC.
Key facts
| Proprietary names | Dressing, Wound, Drug - DeRoyal |
|---|---|
| Owner/operator | DEROYAL INDUSTRIES, INC. |
| Owner/operator number | 1044833 |
| Premarket submissions | K011618 |
| Product codes | FRO |
| Device names | FRO - Dressing, Wound, Drug |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.FRO |
| Review panels | General & Plastic Surgery |
| Registered establishments | DeRoyal Industries, Inc., DEROYAL INDUSTRIES, INC., Guatemala Medical Manufacturing, Ortho and Surgical Products Enterprises S.A. |
| Establishment registrations | 1034876, 1043214, 1060680, 2320762, 3010452421, 3045857302 |
| FEI numbers | 1034876, 1043214, 1000208624, 3003040625, 3010452421, 3045857302 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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