BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tracey-VFA Visual Function Analyzer

    DI: 00860479001706 · Model: iTrace · TRACEY TECHNOLOGIES, CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tracey-VFA Visual Function Analyzer
    Primary DI
    00860479001706
    Version / Model
    iTrace
    Catalog Number
    Z2000
    Company Name
    TRACEY TECHNOLOGIES, CORPORATION
    Labeler DUNS
    027572366
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-09
    Public Version
    3
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    35035323-c3d7-43c3-a039-eed05c58af81

    Device Description

    The iTrace is used to measure the refractive, wavefront and corneal topographic data of the human optical system.

    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
    NCF Aberrometer, Ophthalmic

    GMDN Terms

    Code Name
    18038 Corneal topography system
    36386 Automated ophthalmic refractometer

    Identifiers

    Type ID
    Primary 00860479001706