BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Summit8301 (DV) - HiVac7 Bone Cement Mixing and Delivery System (Triple application) C703

    Reg #: 3002807314 · FEI: 3002807314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Synergy Health Ireland Ltd
    Registration Number
    3002807314
    FEI Number
    3002807314
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    IDA Business and Technology Park
    City
    Tullamore Offaly
    Country
    IE

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10042227
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    US Agent

    Business Name
    Synergy Health
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Rd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 3927490

    Products

    Device Name Product Code
    Dispenser, Cement KIH

    Proprietary Names

    Summit8301 (DV) - HiVac7 Bone Cement Mixing and Delivery System (Triple application) C703 Summit8301 (DV) - HiVac7 with Femoral Cement Pressuriser CP701, CP702 Escoffier11264 (MC) - DISPENSER, CEMENT Summit8301 (DV) - 9mm Nozzle with Nozzle Extruder

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)