BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Tutopatch DM Graft

    Reg #: 3002924436 · FEI: 3002924436 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Tutogen Medical GmBH
    Registration Number
    3002924436
    FEI Number
    3002924436
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Industriestrasse 6
    City
    Neunkirchen am Brand Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K132850

    Owner / Operator

    Firm Name
    RTI Surgical, Inc. (dba RTI Biologics, Inc.)
    Operator Number
    1641375
    Address
    11621 Research Circle
    City
    Alachua
    State
    FL
    Postal Code
    32615
    Country
    US
    Correspondent
    Amanda LoGuidice

    Products

    Device Name Product Code
    Dura Substitute GXQ

    Proprietary Names

    Tutopatch DM Graft Tutoplast Bovine Pericardium DM Bovine Pericardium Suturable Dural Graft

    Establishment Types

    Manufacture Medical Device