BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DuraGraft

    Reg #: 3011421726 · FEI: 3011421726 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Marizyme, Inc.
    Registration Number
    3011421726
    FEI Number
    3011421726
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    555 Heritage Drive, Suite 205
    City
    Jupiter
    State
    FL
    ZIP
    33458
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240925

    Owner / Operator

    Firm Name
    Marizyme, Inc.
    Operator Number
    10081557
    Address
    555 Heritage Drive, Suite 205
    City
    Jupiter
    State
    FL
    Postal Code
    33458
    Country
    US
    Correspondent
    David Barthel

    Products

    Device Name Product Code
    Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries QEJ

    Proprietary Names

    DuraGraft

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility