BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Labomed Stella OPH microscope with wall mount

    DI: 08908006463268 · Model: 6219101 · 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 Stella OPH microscope with wall mount
    Primary DI
    08908006463268
    Version / Model
    6219101
    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
    19264290-04f2-448f-b655-f5f0f9175e86

    Device Description

    '- Maxlite coated Motorized 5 Step Zoom, 0.4X, 0.6X, 1.0X, 1.6X, 2.5X - Galilean optical system with high resolution, high depth of field and perfect RedReflex . - 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply - 0° - 210° tiltable binocular head, f-140mm. IPD 49-78mm, configured with DBS (Double beam splitter ), Double iris, MaxLite(TM) optics - f=200mm CMO - WF 10x/18mm eyepieces with diopter lock and foldable eyeguard - Swivel arm (470mm Long, + 180° rotatable altogether with column for better stability and balancing). - suspension arm (1000mm Long, + 180° rotation) with locking knobs, tension control knobs, downward limit stop and LED shut-off in park position - Motorized XYZ carrier with autolock tiltable mechanism, XY reset button and provision for fundus viewing attachment (BIOM image invertor). - 10 function wired foot switch for XY & Z axis movements, Magnification changer and intensity control. - Wall mount - Flip in/out blue blocking yellow filter. Retro illumination contrast stops and retinal protection device. Red free green filter. - can be upgraded with Assistant Viewing Attachment, Camera Adapter and iphone adapters

    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 08908006463268