BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    plusoptiX 12

    DI: 04260184512119 · Model: A12C · Plusoptix GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    plusoptiX 12
    Primary DI
    04260184512119
    Version / Model
    A12C
    Catalog Number
    A12C
    Company Name
    Plusoptix GmbH
    Labeler DUNS
    332755078
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-20
    Public Version
    1
    Public Version Date
    2022-10-28
    Public Version Status
    New
    Public Device Record Key
    cc2e4a76-7c44-4949-b0de-2f303ccb6cee

    Device Description

    The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HKO Refractometer, Ophthalmic

    GMDN Terms

    Code Name
    61569 External ocular measurement camera

    Identifiers

    Type ID
    Primary 04260184512119
    Package 04260184512126