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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Labomed Prima DNT Microscope Wall mount

    DI: 08908006463046 · Model: 6137101 · 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 Prima DNT Microscope Wall mount
    Primary DI
    08908006463046
    Version / Model
    6137101
    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
    2022-12-13
    Public Version
    1
    Public Version Date
    2022-12-21
    Public Version Status
    New
    Public Device Record Key
    bbab90f1-3288-4bfe-85c9-270fda7c7e10

    Device Description

    The Labomed Prima DNT Microscope with Wall mount is a surgical and diagnostic microscope which is adaptable for different surgical needs for consistent visualization during all intra operative phases of dentistry surgeries by providing magnified view of the surgical field without compromise to performance. The microscope provides extremely high optical image quality, good depth of focus and wide field of view for precise surgery. Illumination control, inbuilt tilt, adjustment of the observation head help to reduce the Surgeon's work fatigue and allow comfortable use over 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 5-step magnification changer allows an optimal magnification for a particular surgery from five different magnifications. 3. Cold light illumination with a high intensity 50W LED lamp is provided in magnichanger for proper illumination. The illumination is further adjustable up to its most suitable brightness using intensity control knob suitably located at the suspension arm, and is easily approachable to the surgeon. 4. When the microscope is not in use, the suspension arm can be folded over the main body to store it compactly. 5. Dual iris Diaphragm allows greater depth of field particularly valuable for photography. INTENDED USE Prima Surgical Microscope is an AC powered device intended for use during diagnosis and Surgery to provide a magnified view of surgical field.

    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 08908006463046