BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DuraSorb Monofilament Mesh

    Reg #: 3015194982 · FEI: 3015194982 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SURGICAL INNOVATION ASSOCIATES, INC.
    Registration Number
    3015194982
    FEI Number
    3015194982
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    445 W Erie St, Suite 111
    City
    Chicago
    State
    IL
    ZIP
    60654
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181094

    Owner / Operator

    Firm Name
    Integra LifeSciences Corporation
    Operator Number
    9004007
    Address
    1100 Campus Rd
    City
    Princeton
    State
    NJ
    Postal Code
    08540
    Country
    US

    Products

    Device Name Product Code
    Mesh, Surgical, Polymeric FTL

    Proprietary Names

    DuraSorb Monofilament Mesh

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility