BEUDAMED
    FDA Registration Active 🇫🇷 France

    Integra DP Valve System

    Reg #: 3007156625 · FEI: 3008133910 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    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
    K861377

    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

    Integra DP Valve System Integra DP Valve Systems, stainless steel connectors, burr hole reservoirs and caps Ventricular, atrial and peritoneal catheters Subcutaneous Tube Passer

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)