BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Holmium Laser Fiber Single Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems

    Reg #: 1000393132 · FEI: 1000393132 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COOK INCORPORATED
    Registration Number
    1000393132
    FEI Number
    1000393132
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6300 N. MATTHEWS DR.
    City
    ELLETTSVILLE
    State
    IN
    ZIP
    47429
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133788

    Owner / Operator

    Firm Name
    COOK, INC.
    Operator Number
    1820334
    Address
    750 DANIELS WAY
    City
    Bloomington
    State
    IN
    Postal Code
    47404
    Country
    US

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Holmium Laser Fiber Single Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems Holmium Laser Fiber Multi Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)