FDA device listing
BARTELS BUCKET HANDLE,BARTELS BUCKET HANDLE OFFSET,DE LA CRUZ PISTON,FLUOROPLASTIC PISTON,GRACE BUCKET HANDLE…
FDA device listing 1363680801 · GRACE MEDICAL GROUP, INC.
Key facts
| Proprietary names | BARTELS BUCKET HANDLE,BARTELS BUCKET HANDLE OFFSET,DE LA CRUZ PISTON,FLUOROPLASTIC PISTON,GRACE BUCKET HANDLE OFFSET,GRACE MALLEUS PISTON,Grace Medical,GRACE MEDICAL FLUOROPLASTIC PISTON,GRACE MEDICAL TITANIUM/FLUOROPLASTIC PISTON,GRACE MEDICAL TITANIUM ROUND WIRE PISTON,GRACE PISTON,LINSTROM PISTON,LIPPY BUCKET,LIPPY BUCKET HANDLE W/NOTCH,MAZZAWI PISTON,MEITI PISTON,ROBINSON BUCKET,ROBINSON… |
|---|---|
| Owner/operator | GRACE MEDICAL GROUP, INC. |
| Owner/operator number | 9067138 |
| Premarket submissions | K060518 |
| 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 | GRACE MEDICAL, INC. |
| Establishment registrations | 1057421 |
| FEI numbers | 1000022662 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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