FDA device listing
Acclarent,Integra,Integra Luxtec DLX UltraLite Pro,Light Guide Cable Adapters,Luxtec Fiber Optic…
FDA device listing 1870506591 · Integra LifeSciences Corporation
Key facts
| Proprietary names | Acclarent,Integra,Integra Luxtec DLX UltraLite Pro,Light Guide Cable Adapters,Luxtec Fiber Optic Cables,MicroFrance,Miltex,Padgett,Relieva Luma Light Guide Cable 2 |
|---|---|
| Owner/operator | Integra LifeSciences Corporation |
| Owner/operator number | 9004007 |
| Product codes | EQH |
| Device names | EQH - Source, Carrier, Fiberoptic Light |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.4350 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Integra LifeSciences Corporation, INTEGRA LIFESCIENCES CORPORATION, INTEGRA LIFESCIENCES (IRELAND) LIMITED, INTEGRA MICROFRANCE SAS |
| Establishment registrations | 9680837, 3003418325, 3004608878, 3006697299 |
| FEI numbers | 3003249645, 3003418325, 3004608878, 3006697299 |
| Establishment operations | Complaint File Establishment, Specification Developer, 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