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510(k) Data Aggregation

    K Number
    K222740
    Device Name
    Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch
    Date Cleared
    2024-10-21

    (773 days)

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

    Speciality Fibres and Materials Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Under the supervision of a healthcare professional, Venus Ag may be used for the management of: - · wounds with moderate to heavy exudate - · partial thickness burns - · leg ulcers, pressure ulcers and diabetic ulcers - · surgical wounds (e.g. post-operative, wounds left to heal by secondary intent and donor/graft sites) - · traumatic wounds (e.g. abrasions and lacerations) - wounds that are prone to bleeding, such as wounds that have been mechanically debrided and donor sites. The product is for a single use only.
    Device Description
    Venus Ag 120, 160 and 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber are a soft, conformable non-woven fabrics made from sodium carboxymethyl cellulose and strengthening cellulose fiber(s) with antimicrobial silver. The silver in the wound dressing, when in contact with wound exudate or blood present in wound exudate, has an antimicrobial effect on bacteria held within the dressing, preventing it from being colonized. The absorption of exudate into the dressing forms a gel which assists in maintaining a moist wound environment, supporting autolytic debridement, protects the wound edge and surrounding skin from maceration. Through the gel formation the structure of the dressing remains intact. Debris and any bacteria found in the wound exudate can be retained inside the dressing and removed when the dressing is changed. When dry, Venus Ag can easily be cut to the size of the wound. The device is a combination product, code FRO. Venus Ag dressings are supplied in a variety of sizes, configurations, and weights.
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    K Number
    K183208
    Device Name
    Suprasorb A + Ag “R”
    Date Cleared
    2019-08-15

    (269 days)

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

    Speciality Fibres and Materials Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Suprasorb® A +Ag "R" can be used for the management of wounds, in adult patients only, which are: - · Moderately and heavily exuding - · Superficial or - · Deep Such as: - Pressure sores - Arterial Ulcers - · Venous lower leg ulcers - · Diabetic ulcers - · Post-operative wounds
    Device Description
    Suprasorb® A + Ag "R" is a calcium alginate dressing with antibacterial silver. This device is a minor modification of the predicate device in which regenerated cellulose fibers (Tencel®) for strengthening purposes has been added. The dressings are also made in 2 variants namely 120 gsm and 200 gsm (in line with customer requirements for various options when choosing suitable size dressing for a wound) and are soft, conformable wound covers with a high mannuronic acid content. The silver in the wound dressing has an antibacterial effect upon various types of bacteria including Staphylococcus aureus and Escherichia coli. The silver ions protect the dressing from a broad spectrum of bacterial contamination over a period of up to 5 days in the in vitro challenge test. The Suprasorb® A + Ag "R" Calcium Alginate Dressings with antibacterial silver (reinforced variant) are sterilized by irradiation and must not be re-sterilized. The product remains sterile unless the package is opened or damaged. Single use only should be applied and the product is for prescription use only.
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