BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DragonFly, POWERED BY InvisiDrive HANDPIECE

    Reg #: 1057421 · FEI: 1000022662 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GRACE MEDICAL, INC.
    Registration Number
    1057421
    FEI Number
    1000022662
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8500 WOLF LAKE DR. SUITE 110
    City
    Memphis
    State
    TN
    ZIP
    38133
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161376

    Owner / Operator

    Firm Name
    GRACE MEDICAL GROUP, INC.
    Operator Number
    9067138
    Address
    8500 WOLF LAKE DR., SUITE 110
    City
    Memphis
    State
    TN
    Postal Code
    38133
    Country
    US

    Products

    Device Name Product Code
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL

    Proprietary Names

    DragonFly, POWERED BY InvisiDrive HANDPIECE DragonFly DragonFly STERILIZATION TRAY DragonFly ANGLED ADAPTOR-15° DragonFly ANGLED ADAPTOR-35° DragonFly CHARGING SYSTEM DragonFly SURGICAL DRILL SYSTEM POWERED BY Invisidrive DragonFly FOOTSWITCH DragonFly ANGLED ADAPTOR-25° DragonFly BATTERY SET

    Establishment Types

    Manufacture Medical Device