FDA Device Establishments · JSON-LD · Markdown
FEI 2219920 · Sterilize Medical Device for Another Party (Contract Sterilizer) · Status: Active
| FEI Number | 2219920 |
|---|---|
| Owner / Operator | Sotera Health LLC (#10029425) |
| Address | 108 Lake Denmark Rd, Rockaway, NJ, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JOH |
| Regulation § (21 CFR) | 868.5800 |
| Proprietary names | ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 9MM BLU TUBE +2/CA Portex UltraPerc Sing; ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 8MM BLU TUBE +2/CA Portex UltraPerc Sing; Portex Ultraperc; K041348; ULTRAPERC LOCAL INFILTRATION (SDD) W/DRUGS + 10/CA Portex UltraPerc Local Infiltration Tray; ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 8MM BLUS TUBE +2/CA Portex UltraPerc Sin; ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 9MM BLUS TUBE +2/CA Portex UltraPerc Sin; ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 7MM BLU TUBE +2/CA Portex UltraPerc Singl; ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 7MM BLUS TUBE +2/CA Portex UltraPerc Sin; ULTRAPERC PERC S/S DILATION TRACHY KIT FOR 7, 8, 9MM TUBES, SOFT INTRODUCERS, 2/CA Portex UltraPerc Percutaneous T |
Source: openFDA. Public-domain (CC0).