FDA device listing
OmegaSurgical14385 (LSRTC, LS) - BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL,OrchidUnique5936 (LN) - Blade, Saw…
FDA device listing 1833435494 · STERIS Corporation
Key facts
| Proprietary names | OmegaSurgical14385 (LSRTC, LS) - BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL,OrchidUnique5936 (LN) - Blade, Saw, General & Plastic Surgery, Surgical - Signature Series UltraLite,StrykerPR3324 (GR) - 4.0 mm ENT MicroDebrider AGGRESSIVE SERRATED,StrykerPR3324 (GR, LS) - 4.0mm Aggressive Serrated,StrykerPR3324 (GR, LS, VG) - Bur TMJ 2.0mm,StrykerPR3324 (GR, LS, VG) - Bur TMJ 3.0mm,StrykerPR3324… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 1527821 |
| Product codes | GFA |
| Device names | GFA - Blade, Saw, General & Plastic Surgery, Surgical |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Isomedix Operations, Inc., ISOMEDIX OPERATIONS INC, STERIS ISOMEDIX PUERTO RICO, INC. |
| Establishment registrations | 1424263, 1450662, 1526711, 2183744, 2648623 |
| FEI numbers | 1450662, 1526711, 2183744, 2648623, 3003015552 |
| Establishment operations | Contract Sterilizer |
| 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