BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ovitz Aberrometer

    DI: 08908007754082 · Model: P10 · FORUS HEALTH PRIVATE LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ovitz Aberrometer
    Primary DI
    08908007754082
    Version / Model
    P10
    Company Name
    FORUS HEALTH PRIVATE LIMITED
    Labeler DUNS
    864213893
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-22
    Public Version
    3
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    fd9566d5-2550-45f9-9df8-5114e5d7ae04

    Device Description

    OVITZ P10 is an ophthalmic aberrometer. It uses Wavefront Sensing technology for accurate and reliable refractive measurements in human eyes. It is compact and completely portable, with a light weight body and long-lasting battery. It has a high resolution, touchscreen color display. An ergonomic handle gives the user a comfortable control in handling of the device.

    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
    Yes
    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 08908007754082