FDA device listing
Manual surgical instrument for general use
FDA device listing 1081091684 · Medtronic, Inc.
Key facts
| Proprietary names | Manual surgical instrument for general use |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Product codes | GDF |
| Device names | GDF - Guide, Needle, Surgical |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Medtronic (Changzhou) Medical Devices Technology Co., Ltd, Medtronic Engineering and Innovation Center (MEIC), MEDTRONIC SOFAMOR DANEK USA, INC., WARSAW ORTHOPEDIC, INC. |
| Establishment registrations | 1030489, 1824199, 3005677016, 3018094310 |
| FEI numbers | 1824199, 1000477302, 3005677016, 3018094310 |
| Establishment operations | Complaint File Establishment, 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