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510(k) Data Aggregation

    K Number
    K040283
    Device Name
    BIOPAD
    Manufacturer
    EURORESEARCH S.R.L.
    Date Cleared
    2005-07-22

    (532 days)

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

    EURORESEARCH S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIOPAD® is a collagen wound dressing intended for the control of minor bleeding, and for the local management of moderately to heavy exuding wounds including: - pressure ulcers, - venous stasis ulcers, - diabetic ulcers, - partial and full thickness wounds, - surgical and traumatic wounds, - surgicul and other bleeding surface wounds - dehisced surgical incisions - draining wounds - lacerations - podiatric - post-laser surgery The product is supplied sterile and for one-time-use only.
    Device Description
    BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management of any kind of ulcer and skin lesion to help wound closure. BIOPAD® is a sponge shaped device, constituted exclusively by lyophilized type 1 native heterologous collagen extracted from horse flexor tendon. When applied to a wound, BIOPAD® constitutes a barrier for wound against exogenous infective agents. BIOPAD® is the ideal first-aid means to control minor bleeding. The device may be used by healthcare professionals. BIOPAD® is supplied sterile and for one-time use only.
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