FDA device listing
Dispenser for 524 Series Disposable Ear Spec
FDA device listing 1107622560 · BAXTER HEALTHCARE CORPORATION
Key facts
| Proprietary names | Dispenser for 524 Series Disposable Ear Spec |
|---|---|
| Owner/operator | BAXTER HEALTHCARE CORPORATION |
| Owner/operator number | 1417572 |
| Product codes | JYK |
| Device names | JYK - Holder, Ear Speculum |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.1800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V., WELCH ALLYN, INC. |
| Establishment registrations | 1316463, 3006087789 |
| FEI numbers | 1316463, 3006087789 |
| Establishment operations | Contract Manufacturer, 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