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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Auto Ref/Keratometer HRK-8100A

    DI: 08800019600923 · Model: HRK-8100A · Huvitz Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Auto Ref/Keratometer HRK-8100A
    Primary DI
    08800019600923
    Version / Model
    HRK-8100A
    Company Name
    Huvitz Co., Ltd.
    Labeler DUNS
    688154202
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-24
    Public Version
    1
    Public Version Date
    2023-09-01
    Public Version Status
    New
    Public Device Record Key
    38735d96-5f12-4c55-92d1-8d5cce907a30

    Device Description

    Auto Ref/Keratometer HRK-8100A is intended to provide the information of Spherical, Cylindrical and Axis while measuring the refraction of examinee’s 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
    Yes
    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 08800019600923