FDA device listing
Intuitive5779 (SDA,GP) - Xi Harmonic ACE
FDA device listing 1703496387 · STERIS Corporation
Key facts
| Proprietary names | Intuitive5779 (SDA,GP) - Xi Harmonic ACE |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 9072619 |
| Product codes | LFL, NAY |
| Device names | LFL - Instrument, Ultrasonic Surgical, NAY - System, Surgical, Computer Controlled Instrument |
| Device class | Class II, Unclassified |
| Classification regulations (21 CFR) | 876.1500, ORCA1.LFL |
| Review panels | Gastroenterology & Urology, General & Plastic Surgery |
| Registered establishments | Isomedix Operations Inc. |
| Establishment registrations | 1650907, 2032112 |
| FEI numbers | 3002681132, 3003076831 |
| 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