BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRACH DIC UNCF 10MM +1/EA Portex D.I.C Trach

    Reg #: 1319639 · FEI: 1000138054 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    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
    K903730

    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, Tracheostomy (W/Wo Connector) BTO

    Proprietary Names

    TRACH DIC UNCF 10MM +1/EA Portex D.I.C Trach TRACH DIC UNCF 6MM + 1/EA Portex D.I.C Trach TRACH DIC UNCF FEN 7MM + 1/EA Portex Uncuffed Fenestrated D.I.C. Trach TRACH DIC UNCF FEN 8MM + 1/EA Portex Uncuffed Fenestrated D.I.C. Trach IN CAN LARYNGECTOMY TU 8MM + 10/BX Portex Laryngectomy Trach IN CAN LARYNGECTOMY TU 9MM + 10/BX Portex Laryngectomy Trach TRACH DIC UNCF 8MM + 1/EA Portex D.I.C Trach TRACH DIC UNCF FEN 6MM + 1/EA Portex Uncuffed Fenestrated D.I.C. Trach K903730 IN CAN LARYNGECTOMY TU 10MM+ 10/BX Portex Laryngectomy Trach TRACH DIC UNCF 7MM + 1/EA Portex D.I.C Trach TRACH DIC UNCF FEN 10MM + 1/EA Portex Uncuffed Fenestrated D.I.C. Trach TRACH DIC UNCF FEN 9MM + 1/EA Portex Uncuffed Fenestrated D.I.C. Trach TRACH DIC UNCF 9MM + 1/EA Portex D.I.C Trach

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)