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510(k) Data Aggregation

    K Number
    K142473
    Device Name
    Lubricating Jelly
    Manufacturer
    SION BIOTEXT MEDICAL LTD
    Date Cleared
    2015-04-13

    (222 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
    Why did this record match?
    Applicant Name (Manufacturer) :

    SION BIOTEXT MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required.
    Device Description
    Sion's Lubricating Jelly is used to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required. Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc. The lubricating jelly is clear, greaseless, odorless, water soluble and non-irritating to the skin, tissue and mucous membranes. Both product types (sterile and non-sterile) are packed in a bacterial barrier tubes or sealed laminated sachets. Sion's Lubricating Jelly is a body contact material and was evaluated for biocompatibility with accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2009.
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