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    K Number
    K141721
    Device Name
    BOVINE PERICARDIUM PATCH
    Manufacturer
    Date Cleared
    2014-12-22

    (180 days)

    Product Code
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLLAFIRM LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Bovine Pericardium Patch is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following: Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy / pneumectomy, pneumoreduction) and other incisions and excision of the lung and bronchus. Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).
    Device Description
    The Bovine Pericardium Patch is intended for use as an implant to reinforce soft tissue where weakness exists. The Boyine Pericardium Patch is derived from bovine pericardium tissue. The tissue is subjected to decontamination and decellularization processing using non-toxic reagents. The resulting mesh is intended for use as a resorbable implant for soft tissue repair which subsequently remodels and is integrated in the host connective tissue. The Bovine Pericardium Patch is terminally sterilized and is available in sizes ranging from 2cm x10cm to 8cm x16cm.
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    K Number
    K120250
    Device Name
    FIBRILLAR COLLAGEN WOUND DRESSING
    Manufacturer
    Date Cleared
    2013-04-21

    (450 days)

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

    COLLAFIRM LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CollaFirm Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including; pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular origin, venous ulcers, donor and graft sites, abrasions, traumatic wounds healing by secondary intention, dehisced surgical wounds, first and second degree burns. For Prescription use
    Device Description
    CollaFirm Collagen Wound Dressing, a highly purified porcine Type I, collagen wound dressing which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound environment in the management of wound healing. The CollaFirm Collagen Wound Dressing is provided in a patient ready, one (1) gram, envelop.
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