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510(k) Data Aggregation

    K Number
    K183622
    Device Name
    NasalCEASE and BleedCEASE
    Date Cleared
    2019-12-02

    (341 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Les Laboratoires Brothier S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OTC: For the local management of bleeding wounds such as minor lacerations, minor abrasions, and minor nosebleeds. Prescription: For nasal epistaxis and the local management of topical wounds, including both non-infected: - · Small bleeding surface wounds - · Small post-surgical incisions - Abrasions and lacerations
    Device Description
    BleedCEASE® and NasalCEASE® are the same product with the same indications for use but branded under two different names. The remainder of this summary will refer to the product as BleedCEASE. BleedCEASE® is made of calcium alginate, an all-natural biopolymer originating from seaweed. When in contact with the wound, BleedCEASE® absorbs blood and releases calcium, becoming a soft gel that conforms to the wound. BleedCEASE stops bleeding without sticking to the wound, reducing the likelihood of pain or rebleeds that may be associated with wound dressing removal. BleedCEASE® is provided as a sterile, non-woven packing (2cm x 4cm), each packaged in an individual pouch. The product is sold in boxes of 5, 25 and 100 pouches.
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