FDA device listing
Ear Irrigation Kit with irrigation bulb syringe,Wax Blaster MD Ear Irrigation and Cleaning Kit with Ear Clean MD
FDA device listing 1039793340 · Eosera Inc
Key facts
| Proprietary names | Ear Irrigation Kit with irrigation bulb syringe,Wax Blaster MD Ear Irrigation and Cleaning Kit with Ear Clean MD |
|---|---|
| Owner/operator | Eosera Inc |
| Owner/operator number | 10058317 |
| Product codes | OGQ |
| Device names | OGQ - Ear Irrigation Kit |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6960 |
| Review panels | General Hospital |
| Registered establishments | EOSERA INC |
| Establishment registrations | 3013559620 |
| FEI numbers | 3013559620 |
| Establishment operations | Complaint File Establishment, 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