FDA device listing
TRAYS AND RACKS.,VARIOUS TYPES OF CASES
FDA device listing 1754316897 · SYNTHES (USA) Products LLC / Medical Device Business Service
Key facts
| Proprietary names | TRAYS AND RACKS.,VARIOUS TYPES OF CASES |
|---|---|
| Owner/operator | SYNTHES (USA) Products LLC / Medical Device Business Service |
| Owner/operator number | 2520274 |
| Product codes | FSM |
| Device names | FSM - Tray, Surgical, Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | DePuy Synthes Sales, Synthes (USA) Products LLC |
| Establishment registrations | 3008812560, 3034676720 |
| FEI numbers | 3008812560, 3034676720 |
| Establishment operations | Complaint File Establishment, 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