BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Band, Elastic, Orthodontic

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    68
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029275
    FEI Number
    1000306431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    344 Bonnie Cir
    City
    Corona
    State
    CA
    ZIP
    92878
    Country
    US

    Regulatory Submissions

    510(k) Number
    K882695

    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
    Band, Elastic, Orthodontic ECI

    Proprietary Names

    Band, Elastic, Orthodontic 19100/30 14903/50 18008/25 14602/50 18006/20 14608/100 14884/50 14612/100 14601/25 14110/100 14012/100 19030/50 19125/50 14712/100 18010/20 14005/100 14602G/25 14602D/100 14705/100 14202/100 18003/50 14930/100 14118/100 19112/25 14162/100 19060/50 14010/100 14205/50 14204LT/100 19085/50 19012/50 14704/100 14605/100 19112/24 19100/50 19115/50 14802/50 14715/100 14702N/100 14710/100 987370/50 19020/50 14702/100 14011/100 19114/24 19010/50 14830/50 14802/100 14220/100 19111/50 14920/100 19005/50 14002/100 14102/100 14602/100 14902/50 14004/100 19110/50 14364/100 19116/50 19127/50 14707/100 14909/50 14706/100 14203/50 14606/100 19070/50

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)