BEUDAMED
    FDA Registration Active 🇺🇸 United States

    450.844S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    150
    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
    K970733

    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
    Pin, Fixation, Smooth HTY

    Proprietary Names

    450.844S 450.791S 450.714S 0405.666S 0405.658S 450.710S 459.72S 0405.680S 450.703S 450.787S 450.792S 450.812S 450.871S 450.824S 0405.626S 450.855S 450.866S 459.90S 450.706S 450.713S 0405.622S 459.26S 450.867S 450.716S 0405.632S 450.862S 0405.640S 450.861S 0405.644S 450.835S 450.711S 450.786S 450.870S 450.848S 459.48S 450.815S 450.790S 450.794S 450.828S 450.804S 450.806S 450.810S 450.872S 450.789S 450.809S 459.40S 450.708S 450.705S 450.802S 450.827S 450.864S 459.56S 450.715S 450.851S 450.825S 450.822S 450.823S 450.875S 459.95S 459.85S 459.30S 0405.685S 450.846S 450.813S 459.38S 450.788S 459.64S 459.80S 0405.646S 450.821S 450.782S 0405.628S 450.712S 450.845S 450.843S 450.704S 459.76S 450.841S 450.868S 450.795S 450.785S 450.831S 450.781S 450.849S 450.826S 450.702S 450.803S 450.833S 0405.636S 450.830S 459.32S 0405.642S 0405.630S 459.100S 0405.650S 450.709S 459.44S 450.852S 0405.616S 459.68S 0405.654S 459.36S 450.856S 0405.690S 450.869S 450.816S 450.896S 450.707S 450.783S 450.874S 450.836S 0405.618S 450.796S 450.784S 0405.634S 450.873S 0405.624S 450.842S 450.701S 459.34S 450.853S 459.28S 450.863S 0405.662S 450.865S 450.807S 459.52S 450.805S 459.60S 0405.670S 450.850S 459.42S 450.793S 0405.620S 450.854S 450.847S 459.46S 450.808S 450.801S 0405.675S 0405.648S 459.54S 0405.638S 450.832S 450.811S 459.50S 450.834S 450.829S 450.814S 459.58S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)