FDA device listing
Applebaum incus repl 2.0mm dense ha,Applebaum incus repl 2.25mm dense ha,Applebaum incus repl 2.5mm dense ha,Applebaum…
FDA device listing 1241214495 · MIDWEST STERILIZATION CORP.
Key facts
| Proprietary names | Applebaum incus repl 2.0mm dense ha,Applebaum incus repl 2.25mm dense ha,Applebaum incus repl 2.5mm dense ha,Applebaum incus repl 3.0mm dense ha,Applebaum incus repl 3.5mm dense ha,Goldenberg incus prosth.,Grote incus prosthesis, 1.5mm x 7.0mm,Grote incus prosthesis, hydroxylapatite,Kartush Incus Strut,Kartush incus strut, ha, 2.75mm lng,Kartush incus strut, ha 4.0mm lng,Kartush incus strut, ha… |
|---|---|
| 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