BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AUTO REFRACTOMETER

    DI: 04987669100707 · Model: AR-1s · NIDEK CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AUTO REFRACTOMETER
    Primary DI
    04987669100707
    Version / Model
    AR-1s
    Company Name
    NIDEK CO.,LTD.
    Labeler DUNS
    690635461
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-04-20
    Public Version
    3
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    a9e81e50-5f84-4d0c-bef7-878a5e54dbfe

    Device Description

    The NIDEK AUTO REFRACTOMETER AR-1s measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. In addition, subjective test is performed with the built-in charts and lenses for subjective measurement.

    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
    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
    36386 Automated ophthalmic refractometer

    Identifiers

    Type ID
    Primary 04987669100707

    Customer Contacts

    Phone
    1-800-223-9044
    Email
    [email protected]