FDA device listing
ANNULOPLASTY RING SIZER
FDA device listing 1818896335 · GENESEE BIOMEDICAL, INC.
Key facts
| Proprietary names | ANNULOPLASTY RING SIZER |
|---|---|
| Owner/operator | GENESEE BIOMEDICAL, INC. |
| Owner/operator number | 9012312 |
| Product codes | DTI |
| Device names | DTI - Sizer, Heart-Valve, Prosthesis |
| Device class | Class I |
| Classification regulations (21 CFR) | 870.3945 |
| Review panels | Cardiovascular |
| Registered establishments | GENESEE BIOMEDICAL, INC. |
| Establishment registrations | 1723241 |
| FEI numbers | 1000517719 |
| Establishment operations | Manufacturer, 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