BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NanoZoomer S360MD Slide scanner system

    DI: 04582389010659 · Model: C13220-01MD · HAMAMATSU PHOTONICS K.K.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NanoZoomer S360MD Slide scanner system
    Primary DI
    04582389010659
    Version / Model
    C13220-01MD
    Company Name
    HAMAMATSU PHOTONICS K.K.
    Labeler DUNS
    704524537
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-01
    Public Version
    2
    Public Version Date
    2024-01-09
    Public Version Status
    Update
    Public Device Record Key
    01d9c2d3-5dd3-4461-a5a5-3cde4fcfe989

    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
    PSY Whole Slide Imaging System

    GMDN Terms

    Code Name
    62575 Microscope slide digital imaging scanner IVD

    Identifiers

    Type ID
    Primary 04582389010659

    Premarket Submissions

    Submission Number Supplement Number
    K213883 000
    K233027 000