FDA device listing
ENT Surgical
FDA device listing 1743040392 · COCHLEAR AMERICAS
Key facts
| Proprietary names | ENT Surgical |
|---|---|
| Owner/operator | COCHLEAR AMERICAS |
| Owner/operator number | 9076254 |
| Product codes | LRC |
| Device names | LRC - Instrument, Ent Manual Surgical |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.4420 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | COCHLEAR AMERICAS, Cochlear Americas Warehouse, COCHLEAR BONE ANCHORED SOLUTIONS AB, Cochlear Limited - Brisbane, Cochlear Ltd, COCHLEAR LTD. |
| Establishment registrations | 9613646, 9616024, 3002806740, 3005900820, 3009092818, 3014579188 |
| FEI numbers | 3002806740, 3003045432, 3003222064, 3005900820, 3009092818, 3014579188 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler, 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