FDA device listing
1/4 IN High Torque Hybrid Chuck Reamer w Key,1/4IN Hybrid Chuck Drill w Key,1/4IN Standard Torque Hybrid Chuck Reamer w…
FDA device listing 1933912034 · Celestica
Key facts
| Proprietary names | 1/4 IN High Torque Hybrid Chuck Reamer w Key,1/4IN Hybrid Chuck Drill w Key,1/4IN Standard Torque Hybrid Chuck Reamer w Key,5/32IN Hybrid Chuck Drill w Key,AO High Torque Reamer,AO Standard Torque Reamer,DCS/DHS High Torque Reamer,DCS/DHS Standard Torque Reamer,Double Trigger Handpiece,HAMMR,Hudson Drill,Hudson High Torque Reamer,Hudson Standard Torque Reamer,Pin Driver 2.0-4.0mm,Reciprocating… |
|---|---|
| Owner/operator | Celestica |
| Owner/operator number | 10057437 |
| Product codes | GEY |
| Device names | GEY - Motor, Surgical Instrument, Ac-Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | CELESTICA |
| Establishment registrations | 3010849408 |
| FEI numbers | 3010849408 |
| Establishment operations | Contract Manufacturer |
| 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