FDA device listing
Single Use Handheld Suction Device
FDA device listing 1139355166 · Omnimate Enterprise Co., LTD.
Key facts
| Proprietary names | Single Use Handheld Suction Device |
|---|---|
| Owner/operator | Omnimate Enterprise Co., LTD. |
| Owner/operator number | 10041736 |
| Product codes | GCY |
| Device names | GCY - Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4680 |
| Review panels | General & Plastic Surgery |
| Registered establishments | OMNIMATE ENTERPRISE CO., LTD. |
| Establishment registrations | 3009771213 |
| FEI numbers | 3009771213 |
| Establishment operations | 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