BEUDAMED
    FDA Registration Active 🇫🇷 France

    READY-SET PLUGS, SLIM PLUGS 0.4MM SLIM MINI

    Reg #: 9615745 · FEI: 3000314405 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FCI SAS
    Registration Number
    9615745
    FEI Number
    3000314405
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 rue Carl Zeiss
    City
    BESANCON Doubs
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K961909

    Owner / Operator

    Firm Name
    Carl Zeiss Meditec, Inc.
    Operator Number
    9053564
    Address
    5300 Central Parkway
    City
    Dublin
    State
    CA
    Postal Code
    94568
    Country
    US

    US Agent

    Business Name
    CARL ZEISS MEDITEC USA, INC.
    Contact Name
    Paul Swift
    Address
    5300 Central Parkway
    City
    Dublin
    State
    CA
    ZIP
    94568
    Country
    US
    Email
    [email protected]
    Phone
    817 9258507

    Products

    Device Name Product Code
    Plug, Punctum LZU

    Proprietary Names

    READY-SET PLUGS, SLIM PLUGS 0.4MM SLIM MINI READY-SET PLUGS, SLIM PLUGS 0.5MM SLIM PETITE READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.9MM MEDIUM READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.6MM MICRO READY-SET PLUGS, SLANTED COLLARETTE PLUGS 1MM LARGE READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.7MM MINI PRELOADED PUNCTAL PLUG (REGULAR) - J.A. BERNARD PRELOADED PUNCTAL PLUG (MINI) - J.A. BERNARD TearSaver® – 0.5 mm 2/box TearSaver® – 0.6 mm 2/box TearSaver® – 0.8 mm 2/box PRELOADED PUNCTAL PLUG STRAIGHT COLLARETTE (LARGE) PRELOADED PUNCTAL PLUG (EXTRA SMALL) - J.A. BERNARD PRELOADED PUNCTAL PLUG (MINI US) - J.A. BERNARD PRELOADED PUNCTAL PLUG STRAIGHT COLLARETTE (SMALL) READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.8MM SMALL TearSaver® – 0.7 mm 2/box PRELOADED PUNCTAL PLUG (LARGE) - J.A. BERNARD TearSaver® – 0.4 mm 2/box PRELOADED PUNCTAL PLUG (SMALL) - J.A. BERNARD

    Establishment Types

    Manufacture Medical Device