BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BOND

    DI: 09349458005658 · Model: Cognitive Labeller · 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
    BOND
    Primary DI
    09349458005658
    Version / Model
    Cognitive Labeller
    Catalog Number
    S21.4605
    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
    2024-08-02
    Public Version
    1
    Public Version Date
    2024-08-12
    Public Version Status
    New
    Public Device Record Key
    84599817-8a27-4d82-83f1-895c09822001

    Device Description

    Used to print stick-on labels to attach to slides. The labelled slides are used on the BOND instrument.

    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
    KPA Slide Stainer, Automated

    GMDN Terms

    Code Name
    15599 Microscope slide stainer IVD

    Identifiers

    Type ID
    Primary 09349458005658