BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    St. Jude Pericardial Patch w/Encap

    Reg #: 9680759 · FEI: 3002807088 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GLYCAR SA PTY., LTD.
    Registration Number
    9680759
    FEI Number
    3002807088
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 ALBERT RD., BOX 967
    City
    IRENE Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K963967

    Owner / Operator

    Firm Name
    GLYCAR S.A
    Operator Number
    9011207
    Address
    1 ALBERT RD., --
    City
    IRENE
    State
    Gauteng
    Postal Code
    0062
    Country
    ZA

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ

    Proprietary Names

    St. Jude Pericardial Patch w/Encap

    Establishment Types

    Manufacture Medical Device