BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Labomed Prima OPH microscope (Motorized fine focus & X-Y coupling)

    DI: 08908006463329 · Model: 6135000 · 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 OPH microscope (Motorized fine focus & X-Y coupling)
    Primary DI
    08908006463329
    Version / Model
    6135000
    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
    2023-06-15
    Public Version
    1
    Public Version Date
    2023-06-23
    Public Version Status
    New
    Public Device Record Key
    003db43a-062f-43aa-8677-b358e131b57b

    Device Description

    - MaxLite(TM) optics, 5 step magnification: 0.4x, 0.6x, 1.0x, 1.6x, 2.5x - RedReflex optical system - 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply - 45° inclined binocular head, IPD 55-75mm - f=200mm CMO - WF 10x/16mm eyepieces with diopter lock and foldable eyeguard - Swivel arm (525mm Long, 360° rotation) and suspension arm (600mm Long, 320° rotation) with locking/tension control knobs and LED shut-off in park position - Motorized carrier with XY reset button; foot pedal with joystick to control XY; up/down pedals to control fine focus - Floor stand with H-shape base on castor wheels with brakes - Blue and Green sliding filters, dust cover, and sterilizable knob caps

    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
    HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

    GMDN Terms

    Code Name
    64676 Ophthalmic surgical microscope

    Identifiers

    Type ID
    Primary 08908006463329