FDA device listing
ARMSTRONG R VENT TUBE,BOJRAB TINY TRIUNE,CANOE VENT TUBE,COLLAR BUTTON VENT TUBE,DONALDSON VENT TUBE,GRACE MEDICAL…
FDA device listing 1940345804 · GRACE MEDICAL GROUP, INC.
Key facts
| Proprietary names | ARMSTRONG R VENT TUBE,BOJRAB TINY TRIUNE,CANOE VENT TUBE,COLLAR BUTTON VENT TUBE,DONALDSON VENT TUBE,GRACE MEDICAL T-TUBE,MINI-REVERSIBLE VENT TUBE,MODIFIED COLLAR BUTTON VENT TUBE,PAPARELLA VENT TUBE,PAPARELLA VENT TUBE W/TAB,POPE VENT TUBE,RUBE VENT TUBE W/TAB,SHEA PARASOL VENT TUBE W/TAB,SHEEHY COLLAR BUTTON VENT TUBE,SHEPARD GROMMET VENT TUBE,TAPERVENT TUBE,TINY TRIUNE VENT TUBE,TOUMA VENT… |
|---|---|
| Owner/operator | GRACE MEDICAL GROUP, INC. |
| Owner/operator number | 9067138 |
| Premarket submissions | K981575 |
| Product codes | ETD |
| Device names | ETD - Tube, Tympanostomy |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3880 |
| 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
- 10–99 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