FDA device listing
K041348,Portex Ultraperc,ULTRAPERC LOCAL INFILTRATION (SDD) W/DRUGS + 10/CA Portex UltraPerc Local Infiltration…
FDA device listing 1390933577 · Sotera Health LLC
Key facts
| Proprietary names | K041348,Portex Ultraperc,ULTRAPERC LOCAL INFILTRATION (SDD) W/DRUGS + 10/CA Portex UltraPerc Local Infiltration Tray,ULTRAPERC PERC S/S DILATION TRACHY KIT FOR 7.0, 8.0, 9.0MM TUBES, SOFT INTRODUCERS, 2/CA Portex UltraPerc Percutaneous T,ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 7.0MM BLUS TUBE +2/CA Portex UltraPerc Sin,ULTRAPERC PERCUTANEOUS SINGLE STAGE… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | JOH |
| Device names | JOH - Tube Tracheostomy And Tube Cuff |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5800 |
| Review panels | Anesthesiology |
| Registered establishments | Sterigenics Belgium (Petit Rechain) SRL, Sterigenics UK Limited, Sterigenics U.S., LLC |
| Establishment registrations | 1319639, 2219920, 3005941719, 3008132398 |
| FEI numbers | 2219920, 1000138054, 3002807091, 3002807111 |
| 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