FDA device listing
Arrow® Marked Spring-Wire Guide with Arrow Advancer¿,Arrow® Multi-Lumen Central Venous Catheterization Extreme Kit with…
FDA device listing 1080248500 · Sotera Health LLC
Key facts
| Proprietary names | Arrow® Marked Spring-Wire Guide with Arrow Advancer¿,Arrow® Multi-Lumen Central Venous Catheterization Extreme Kit with Blue FlexTip® ARROWg+ard Blue PLUS® Catheter,Arrow® Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip® ARROWg+ard Blue Plus® Catheter,Arrow® Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip® ARROWg+ard Blue PLUS® catheter,Arrow® Multi-Lumen Central… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | FOZ |
| Device names | FOZ - Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5200 |
| Review panels | General Hospital |
| 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