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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Labomed Magna Wall mount (Long Arm)

    DI: 08908006463152 · Model: 6129301 · LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Labomed Magna Wall mount (Long Arm)
    Primary DI
    08908006463152
    Version / Model
    6129301
    Company Name
    LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
    Labeler DUNS
    919049606
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-15
    Public Version
    1
    Public Version Date
    2022-12-23
    Public Version Status
    New
    Public Device Record Key
    b1bd83f0-674d-4ce5-be47-ff72c794e483

    Device Description

    Labomed Magna DNT Wall mount (Long Arm) microscope is a surgical and diagnostic microscope that is adaptable for different surgical needs for consistent visualization during all intraoperative phases of endodontics by providing a magnified view of the surgical field without compromising performance. The microscope provides extremely high optical image quality, good depth of focus, and a wide field of view for precise surgery. Illumination control and high eye point of the observation head helps reduce the user's work fatigue and allows comfortable use over a long period. Salient features of this microscope are: 1. The observation head can easily be positioned with the help of a suspension arm. 2. An advanced Galilean Zoom 1:6, also convertible to 8 step magnichanger allows optimal magnification for various needs at different magnification levels. 3. Cold light illumination with a high intensity 50W LED lamp is provided using a fiber optic guide for proper illumination. 4. An effortless articulating system ABA (Automatic Balancing Arm) features an electromagnetic brake system that enables the ultimate flexibility in manuvering the microscope's viewing angle and position. 5. The Labomed NuVar CMO with variable working distance objective comes standard, and provides user greater convenience in achieving a comfortable working distance. 6. When the microscope is not in use, the suspension arm can be folded over the main body for compact storage. Intended Use: The Magna microscope is an AC powered device intended for use during diagnosis and surgery to provide a magnified view of the region of interest.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FSO Microscope, Surgical, General & Plastic Surgery

    GMDN Terms

    Code Name
    62439 Dental surgical microscope

    Identifiers

    Type ID
    Primary 08908006463152