BEUDAMED
    FDA Registration Active 🇫🇷 France

    POLARIS® VALVE / 5 PRESS. Low Operating Pressure

    Reg #: 3007156625 · FEI: 3008133910 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics SAS
    Registration Number
    3007156625
    FEI Number
    3008133910
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Rue Parmentier
    City
    Rantigny Oise
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K042481

    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
    Shunt, Central Nervous System And Components JXG

    Proprietary Names

    POLARIS® VALVE / 5 PRESS. Low Operating Pressure POLARIS® SPV-300 ADJUST VALVE / ANTECHAMBER POLARIS® SPV-140 ADJUST VALVE / ANTECHAMBER POLARIS® SPV-400 ADJUST VALVE / ANTECHAMBER POLARIS® VALVE / 5 PRESS. High Operating Pressure

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)