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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Medizs Auto Refractometer-Keratometer

    DI: 08809358430291 · Model: RK-11 · MEDIZS Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Medizs Auto Refractometer-Keratometer
    Primary DI
    08809358430291
    Version / Model
    RK-11
    Catalog Number
    RK-11
    Company Name
    MEDIZS Inc.
    Labeler DUNS
    557804864
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-23
    Public Version
    1
    Public Version Date
    2021-03-31
    Public Version Status
    New
    Public Device Record Key
    85525365-eb8d-45a7-81d7-2e70969c8660

    Device Description

    Medizs Auto Refractometer-Keratometer RK-11 is a refraction device to measure Both of Refractometry & Keratometry. And also, it is able to take patient's PD, Axis and Cylinder value for a prescription of vision correction.

    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
    No
    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
    36386 Automated ophthalmic refractometer

    Identifiers

    Type ID
    Primary 08809358430291