FDA device listing
Integra Luxtec MLX 300 Watt Xenon Light
FDA device listing 1892012339 · Integra LifeSciences Corporation
Key facts
| Proprietary names | Integra Luxtec MLX 300 Watt Xenon Light |
|---|---|
| Owner/operator | Integra LifeSciences Corporation |
| Owner/operator number | 9004007 |
| Product codes | FCW |
| Device names | FCW - Light Source, Fiberoptic, Routine |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Integra Canada ULC, Integra LifeSciences Corporation, INTEGRA LIFESCIENCES (IRELAND) LIMITED, Jarit GmbH |
| Establishment registrations | 3003418325, 3005809810, 3006697299, 3012507533 |
| FEI numbers | 3003418325, 3005809810, 3006697299, 3012507533 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer, 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