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510(k) Data Aggregation

    K Number
    K230645
    Device Name
    BeneHold™ Surgical Incise Drape with CHG antimicrobial II
    Manufacturer
    Avery Dennison Medical Ltd.
    Date Cleared
    2023-10-25

    (231 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    Avery Dennison Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BeneHold™ Surgical Incise Drape with CHG antimicrobial II is indicated for use as an incise drape with continuous antimicrobial activity (in vitro) from 30 minutes through 4 hours of use against the following organisms: S. aureus, S. epidermidis, E. coli, P. aeruginosa, E. aerogenes, and C. albicans. In vitro testing on the subject drape has also shown continuous antimicrobial activity from 30 minutes through 2.5 hours against E. faecalis and F. oxysporum. It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.
    Device Description
    Not Found
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