FDA device listing
Harmony iQ 2400-SLC (RM-CFE),Harmony iQ 2800-SLC (RM-CFE),Harmony iQ 3600-SLC (RM-CFE),Hexalux Sterilizable Light Handle…
FDA device listing 1702483660 · STERIS Corporation
Key facts
| Proprietary names | Harmony iQ 2400-SLC (RM-CFE),Harmony iQ 2800-SLC (RM-CFE),Harmony iQ 3600-SLC (RM-CFE),Hexalux Sterilizable Light Handle (MG-MF),HexaVue Focus Integration System-Surgical Light Control (RM-MF),HexaVue IP In-Light Control Systems (RM-MF),IDSS-SLC (version 7 and 8) (RM-CFE),Sterile Handle Camera Cover (MG-CFE,SD, RO-RR),Sterile Light Handle Cover (MG-CFE,SD, RO-RR),Universal Light Handle Cover… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10078069 |
| Product codes | FTA |
| Device names | FTA - Light, Surgical, Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4580 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Black Diamond Video, Inc., STERIS CORPORATION |
| Establishment registrations | 1043572, 3008776287 |
| FEI numbers | 1043572, 3008776287 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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