FDA device listing
Medtronic Exacta External Drainage and Monitoring System (Exacta EDMS)
FDA device listing 1932979070 · PLEXUS CORP.
Key facts
| Proprietary names | Medtronic Exacta External Drainage and Monitoring System (Exacta EDMS) |
|---|---|
| Owner/operator | PLEXUS CORP. |
| Owner/operator number | 3019588 |
| Product codes | GWM, JXG |
| Device names | GWM - Device, Monitoring, Intracranial Pressure, JXG - Shunt, Central Nervous System And Components |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.1620, 882.5550 |
| Review panels | Neurology |
| Registered establishments | Plexus Manufacturing Sdn. Bhd. |
| Establishment registrations | 3004593495 |
| FEI numbers | 3004593495 |
| 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