FDA device listing
Big Yank,OrthoVAC
FDA device listing 1901927462 · CONMED CORPORATION
Key facts
| Proprietary names | Big Yank,OrthoVAC |
|---|---|
| Owner/operator | CONMED CORPORATION |
| Owner/operator number | 1317214 |
| Product codes | GCX |
| Device names | GCX - Apparatus, Suction, Operating-Room, Wall Vacuum Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6740 |
| Review panels | General Hospital |
| Registered establishments | Conmed Corporation, ConMed Corporation, CONMED CORPORATION, Consolidated Medical Equipment Company, Linvatec Corporation |
| Establishment registrations | 1017294, 1223925, 1320894, 3004491689, 3007305485 |
| FEI numbers | 1017294, 1000305720, 3001451571, 3004491689, 3007305485 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract 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