BEUDAMED
    FDA Registration Active 🇺🇸 United States

    K934465

    Reg #: 1319639 · FEI: 1000138054 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1319639
    FEI Number
    1000138054
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    84 Park Rd
    City
    Queensbury
    State
    NY
    ZIP
    12804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K934465

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Tube, Tracheal (W/Wo Connector) BTR

    Proprietary Names

    K934465 TRACH DIC CUF 10MM + 1/EA Portex Cuffed D.I.C. Trach DECANNULATION CAP + 10/BX Decannulation Cap TRACH DIC CUF 7MM + 1/EA Portex Cuffed D.I.C. Trach TRACH DIC CUF FEN 8MM + 1/EA Portex Cuffed Fenestrated D.I.C. Trach TRACH FLEX DIC CUF 6MM + 1/EA Portex Cuffed Flexi D.I.C. Trach TRACH DIC CUF FEN 7MM + 1/EA Portex Cuffed Fenestrated D.I.C. Trach TRACH DIC CUF FEN 10MM + 1/EA Portex Cuffed Fenestrated D.I.C. Trach TRACH FLEX DIC CUF 7MM + 1/EA Portex Cuffed Flexi D.I.C. Trach TRACH FLEX DIC CUF 8MM + 1/EA Portex Cuffed Flexi D.I.C. Trach TRACH DIC CUF 6MM + 1/EA Portex Cuffed D.I.C. Trach TRACH FLEX DIC CUF 9MM + 1/EA Portex Cuffed Flexi D.I.C. Trach TRACH DIC CUF 9MM + 1/EA Portex Cuffed D.I.C. Trach TRACH DIC CUF FEN 6MM + 1/EA Portex Cuffed Fenestrated D.I.C. Trach TRACH DIC CUF FEN 9MM + 1/EA Portex Cuffed Fenestrated D.I.C. Trach TRACH DIC CUF 8MM + 1/EA Portex Cuffed D.I.C. Trach TRACH FLEX DIC CUF 10MM + 1/EA Portex Cuffed Flexi D.I.C. Trach

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)