FDA device listing
HARTMANN Ear Speculum
FDA device listing 1229542699 · KARL STORZ SE & CO KG
Key facts
| Proprietary names | HARTMANN Ear Speculum |
|---|---|
| Owner/operator | KARL STORZ SE & CO KG |
| Owner/operator number | 8010119 |
| 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 | Karl Storz Endoscopy-America, Inc., KARL STORZ ENDOSCOPY-AMERICA, INC., KARL STORZ SE & CO KG, KARL STORZ SE & CO. KG |
| Establishment registrations | 2020550, 3010202439, 3010707607, 3014342096 |
| FEI numbers | 2020550, 3007475226, 3010707607, 3014342096 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Repackager/Relabeler, 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