BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HistoCore PELORIS

    DI: 09349458004736 · Model: Basket Spaced · LEICA BIOSYSTEMS MELBOURNE PTY LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    HistoCore PELORIS
    Primary DI
    09349458004736
    Version / Model
    Basket Spaced
    Catalog Number
    S45.4505
    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
    5c1dc9fc-8f70-4946-a28f-bbe55057baf7

    Device Description

    Contain cassettes with specimens and are stacked into the retorts. Includes dividers to ensure cassettes are correctly spaced for optimal processing.

    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 09349458004736