FDA device listing
Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter,Expel Drainage Catheter with Twist-Loc Hub…
FDA device listing 1696362911 · Boston Scientific Corporation
Key facts
| Proprietary names | Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter,Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Kit,Flexima Nephrostomy Catheter System,Flexima Nephrostomy Catheter System Kit,Flexima Nephrostomy Catheter System Kit with Dissolving Tip,Flexima Nephrostomy Catheter System with Dissolving Tip,JINRO Pigtail Nephrostomy Catheter,JINRO Pigtail… |
|---|---|
| Owner/operator | Boston Scientific Corporation |
| Owner/operator number | 9912058 |
| Product codes | GBO |
| Device names | GBO - Catheter, Nephrostomy, General & Plastic Surgery |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4200 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Boston Scientific Corp., Marina Bay Cust. Fulfillment Center, Boston Scientific Corporation, BOSTON SCIENTIFIC CORPORATION, Boston Scientific Limited |
| Establishment registrations | 1225687, 1828132, 2124215, 9681260, 1000121056, 3004859241, 3005099803, 3007695959 |
| FEI numbers | 1828132, 2124215, 1000121056, 3001451463, 3002806565, 3004859241, 3005099803, 3007695959 |
| 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