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510(k) Data Aggregation

    K Number
    K033842
    Device Name
    NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE
    Manufacturer
    VERNON-CARUS LIMITED
    Date Cleared
    2004-03-04

    (85 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERNON-CARUS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The family of impervious bags for endoscopic retrieval of tissue are single-use The family of importantes for the collection and extraction and extraction of tissue during laparoscopic surgical procedures. The family includes three sizes of impervious bags for the endoscopic retrieval of tissue: NUBERT (a new bag for the endoscopic retrieval of tissue), ALBERT (a large bag for the endoscopic retrieval of tissue), and HUBERT (a huge bag for the endoscopic retrieval of tissue).
    Device Description
    Single-use disposable device used as a receptacle for the collection and extraction of tissue during laparoscopic surgical procedures.
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