BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ICON Handpiece

    DI: 00857253006019 · Model: PCI 40-1002 · Phoenix Clinical
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ICON Handpiece
    Primary DI
    00857253006019
    Version / Model
    PCI 40-1002
    Company Name
    Phoenix Clinical
    Labeler DUNS
    949114925
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-03
    Public Version
    1
    Public Version Date
    2026-04-13
    Public Version Status
    New
    Public Device Record Key
    7a6d878e-ce12-4233-991f-6d397fb93470

    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
    No
    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
    HKI Camera, Ophthalmic, Ac-Powered

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 00857253006019