BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HistoCore PELORIS

    DI: 09349458005559 · Model: HistoCore I-Scan Kit · LEICA BIOSYSTEMS MELBOURNE PTY LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    HistoCore PELORIS
    Primary DI
    09349458005559
    Version / Model
    HistoCore I-Scan Kit
    Catalog Number
    S45.4507
    Company Name
    LEICA BIOSYSTEMS MELBOURNE PTY LTD
    Labeler DUNS
    753184944
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-18
    Public Version
    2
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    2c2d19fa-e5cf-4b2d-b641-1f231130c328

    Device Description

    A barcode scanner, a built-in camera and an LCD screen t at displays the images captured by the camera. The scanner can be used for performing the same functions as a conventional barcode scanner and the built-in camera is used for capturing images of he baskets filled with cassettes.

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IEO Processor, Tissue, Automated

    GMDN Terms

    Code Name
    57859 Tissue processor IVD, automated/semi-automated

    Identifiers

    Type ID
    Primary 09349458005559