FDA device listing
DRILL GUIDES,EEA TAID,Guide Pin; Introducer Tool,GUIDE WIRES (PINS),LAA Selection Guide
FDA device listing 1754659795 · Medtronic, Inc.
Key facts
| Proprietary names | DRILL GUIDES,EEA TAID,Guide Pin; Introducer Tool,GUIDE WIRES (PINS),LAA Selection Guide |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Product codes | FZX |
| Device names | FZX - Guide, Surgical, Instrument |
| 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 Distribution Center, Medtronic Engineering and Innovation Center (MEIC), MEDTRONIC PERFUSION SYSTEMS, MEDTRONIC SOFAMOR DANEK USA, INC., WARSAW ORTHOPEDIC, INC. |
| Establishment registrations | 1030489, 1824199, 2184009, 3003120897, 3005677016, 3009380063, 3018094310 |
| FEI numbers | 1824199, 1000116158, 1000477302, 3003120897, 3005677016, 3009380063, 3018094310 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, 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