FDA device listing
Arrow® Access Tray,Arrow® Arterial Access Tray,Arrow® Cath-Gard® Catheter Contamination Shield,Arrow® Cath-Gard®…
FDA device listing 1658410045 · Sotera Health LLC
Key facts
| Proprietary names | Arrow® Access Tray,Arrow® Arterial Access Tray,Arrow® Cath-Gard® Catheter Contamination Shield,Arrow® Cath-Gard® Catheter Contamination Shield with Tuohy-Borst Adapter,Arrow® Central Venous Access Tray,Arrow® Central Venous Catheterization/Percutaneous Sheath Introducer Kit,Arrow® Hemostasis Valve Obturator,Arrow® Marked Spring-Wire Guide,Arrow® Percutaneous Sheath Introducer Kit,Arrow®… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | DYB |
| Device names | DYB - Introducer, Catheter |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1340 |
| Review panels | Cardiovascular |
| Registered establishments | Sterigenics U.S., LLC |
| Establishment registrations | 1061124, 1721686 |
| FEI numbers | 1721686, 1000512168 |
| Establishment operations | Contract Sterilizer |
| 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