FDA device listing
IN CAN LARYNGECTOMY TU 10.0MM+ 10/BX Portex Laryngectomy Trach,IN CAN LARYNGECTOMY TU 8.0MM + 10/BX Portex Laryngectomy…
FDA device listing 1529708180 · Sotera Health LLC
Key facts
| Proprietary names | IN CAN LARYNGECTOMY TU 10.0MM+ 10/BX Portex Laryngectomy Trach,IN CAN LARYNGECTOMY TU 8.0MM + 10/BX Portex Laryngectomy Trach,IN CAN LARYNGECTOMY TU 9.0MM + 10/BX Portex Laryngectomy Trach,K903730,TRACH DIC UNCF 10.0MM +1/EA Portex D.I.C Trach,TRACH DIC UNCF 6.0MM + 1/EA Portex D.I.C Trach,TRACH DIC UNCF 7.0MM + 1/EA Portex D.I.C Trach,TRACH DIC UNCF 8.0MM + 1/EA Portex D.I.C Trach,TRACH DIC UNCF… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | BTO |
| Device names | BTO - Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5800 |
| Review panels | Anesthesiology |
| Registered establishments | Sterigenics U.S., LLC |
| Establishment registrations | 1319639 |
| FEI numbers | 1000138054 |
| 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