FDA device listing
RICHPLAT ORTHO 20 PRP System,RICHPLAT ORTHO 40 PRP System,RICHPLAT ORTHO Platelet Rich Plasma System
FDA device listing 1468367281 · Fidia Farmaceutici SPA
Key facts
| Proprietary names | RICHPLAT ORTHO 20 PRP System,RICHPLAT ORTHO 40 PRP System,RICHPLAT ORTHO Platelet Rich Plasma System |
|---|---|
| Owner/operator | Fidia Farmaceutici SPA |
| Owner/operator number | 9027294 |
| Premarket submissions | BK180296 |
| Product codes | ORG |
| Device names | ORG - Platelet And Plasma Separator For Bone Graft Handling |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.9245 |
| Review panels | Hematology |
| Registered establishments | FIDIA FARMACEUTICI SPA |
| Establishment registrations | 9610200 |
| FEI numbers | 3002806986 |
| Establishment operations | Specification Developer |
| 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