BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Actifuse Shape (size 1-2mm/contents 15.8 mL)

    Reg #: 2024024 · FEI: 2024024 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics Radiation Technologies, LLC
    Registration Number
    2024024
    FEI Number
    2024024
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7695 Formula Pl
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090850

    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
    Bone Grafting Material, Synthetic LYC

    Proprietary Names

    Actifuse Shape (size 1-2mm/contents 15.8 mL) Actifuse Shape (size 1-2mm/contents 1.6 mL) Actifuse Shape (size 1-2mm/contents 8 mL) 506005078066-Bone Grafting Material, Synthetic Actifuse Shape (size 1-2mm/contents 8 mL) 506005078064-Bone Grafting Material, Synthetic Actifuse Shape (size 1-2mm/contents 2.6 mL) 506005078062 -Bone Grafting Material, Synthetic Actifuse Shape (size 1-2mm/contents 1.6 mL) Actifuse Shape (size 1-2mm/contents 2.6 mL) 506005078068-Bone Grafting Material, Synthetic Actifuse Shape (size 1-2mm/contents 15.8 mL)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)