BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Graft-Sizer

    Reg #: 3010407203 · FEI: 3010407203 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    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
    K854431

    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

    Graft-Sizer

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)