FDA device listing
Nucleus® HybridTM Cochlear Implant System
FDA device listing 2022185629 · Jabil Inc.
Key facts
| Proprietary names | Nucleus® HybridTM Cochlear Implant System |
|---|---|
| Owner/operator | Jabil Inc. |
| Owner/operator number | 9074019 |
| Product codes | PGQ |
| Device names | PGQ - Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.PGQ |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Jabil Circuit (Shanghai) Ltd. |
| Establishment registrations | 3005210579 |
| FEI numbers | 3005210579 |
| Establishment operations | Contract Manufacturer |
| 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