FDA device listing
Arrow Access Tray,Arrow® Access Tray,Arrow Epidural Anesthesia Kit,Arrow Epidural Catheterization Kit,Arrow Epidural…
FDA device listing 2009737339 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | Arrow Access Tray,Arrow® Access Tray,Arrow Epidural Anesthesia Kit,Arrow Epidural Catheterization Kit,Arrow Epidural Catheterization Kit with FlexTip Plus® Catheter,Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter,Arrow Epidural Catheterization Kit with TheraCath®,Arrow Epidural Catheterization Kit with TheraCath® Catheter,Arrow Epidural Catheterization Set with FlexTip Plus® Closed… |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Product codes | OGE |
| Device names | OGE - Epidural Anesthesia Kit |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5120 |
| Review panels | Anesthesiology |
| Registered establishments | Arrow Internacional de Chihuahua S.A. de C.V., Arrow International C.R. a.s., Arrow International LLC (subsidiary of Teleflex Incorporated), Arrow International, LLC (subsidiary of Teleflex Incorporated) |
| Establishment registrations | 9680794, 3006425876, 3013162291, 3015859709 |
| FEI numbers | 3003737899, 3006425876, 3013162291, 3015859709 |
| Establishment operations | Foreign Exporter, Repackager/Relabeler, 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