BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Intervascular Cardioroot Vascular Graft

    Reg #: 3010407203 · FEI: 3010407203 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics Italy SpA
    Registration Number
    3010407203
    FEI Number
    3010407203
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    via Marzabotto 4
    City
    Minerbio Bologna
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K103347

    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
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY

    Proprietary Names

    Intervascular Cardioroot Vascular Graft Maquet Cardioroot Vascular Graft Intergard Cardioroot Woven Vascular Graft

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)