FDA device listing
Medtronics PS Medical External Drainage and Monitoring (EDM) Ventricular Catheter, 20CM and 35 CM Model 96115 and 96118
FDA device listing 1110222494 · Covidien llc
Key facts
| Proprietary names | Medtronics PS Medical External Drainage and Monitoring (EDM) Ventricular Catheter, 20CM and 35 CM Model 96115 and 96118 |
|---|---|
| Owner/operator | Covidien llc |
| Owner/operator number | 1282497 |
| Product codes | JXG |
| Device names | JXG - Shunt, Central Nervous System And Components |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.5550 |
| Review panels | Neurology |
| Registered establishments | Covidien |
| Establishment registrations | 9612501 |
| FEI numbers | 3003495548 |
| 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