BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PDE-GEN3

    DI: 04582389010871 · Model: C13999-40 · HAMAMATSU PHOTONICS K.K.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PDE-GEN3
    Primary DI
    04582389010871
    Version / Model
    C13999-40
    Company Name
    HAMAMATSU PHOTONICS K.K.
    Labeler DUNS
    704524537
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-01
    Public Version
    1
    Public Version Date
    2023-06-09
    Public Version Status
    New
    Public Device Record Key
    07ba8815-3ef8-4a5e-ae29-daf6ae47c9cb

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IZI System, X-Ray, Angiographic
    OWN Confocal Optical Imaging

    GMDN Terms

    Code Name
    57883 Surgical microscope fluorescent angiography system

    Identifiers

    Type ID
    Primary 04582389010871

    Premarket Submissions

    Submission Number Supplement Number
    K133719 000