FDA device listing
Chen oval top porp w/hole,Goldenberg hapex mal inc 8.2mm,Off ctr porp ha 3mm,Wehrs hapex incus stp dbl,Wehrs hapex incus…
FDA device listing 1218729942 · MIDWEST STERILIZATION CORP.
Key facts
| Proprietary names | Chen oval top porp w/hole,Goldenberg hapex mal inc 8.2mm,Off ctr porp ha 3mm,Wehrs hapex incus stp dbl,Wehrs hapex incus stp sng |
|---|---|
| Owner/operator | MIDWEST STERILIZATION CORP. |
| Owner/operator number | 1928237 |
| Product codes | ETB |
| Device names | ETB - Prosthesis, Partial Ossicular Replacement |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3450 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | MIDWEST STERILIZATION CORP. |
| Establishment registrations | 1928237 |
| FEI numbers | 1928237 |
| Establishment operations | Contract Sterilizer |
| 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