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510(k) Data Aggregation

    K Number
    K241809
    Device Name
    coactiv+™ Antimicrobial Wound Gel
    Manufacturer
    Kane Biotech, Inc.
    Date Cleared
    2024-07-19

    (28 days)

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

    Kane Biotech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rx: The coactiv+™ Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial & full thickness wounds and surgical incisions for adult populations. OTC: The coactiv+™ Antimicrobial Wound Gel is indicated for management of minor lacerations, minor burns (1st degree burns) and abrasions for adult populations.
    Device Description
    The coactiv+™ Antimicrobial Wound Gel is a white, odorless gel that provides a moist wound environment conducive to wound healing. The coactiv+™ Antimicrobial Wound Gel provides preservative properties through an antimicrobial (PHMB) to help inhibit microbial colonization within the gel during shelf storage. Chronic wounds are known to contain non-viable tissue. The coactiv+™ Antimicrobial Wound Gel can facilitate debridement through a moist wound environment. The coactiv+™ Antimicrobial Wound Gel contains water, Poloxamer 407, Glycerol, Trisodium citrate, PHMB (0.1% w/w), Citric acid, Disodium EDTA. The coactiv+™ Antimicrobial Wound Gel dressing will be supplied in 0.7 oz. (21 g) white/opaque polypropylene (19 x 100 mm) screw cap tubes. The device will be available as both a Rx and OTC product.
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    K Number
    K223259
    Device Name
    coactiv+™ Antimicrobial Wound Gel
    Manufacturer
    Kane Biotech, Inc.
    Date Cleared
    2023-05-24

    (212 days)

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

    Kane Biotech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rx: The coactiv+™ Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial & full thickness wounds, large surface area wounds and surgical incisions for adult populations. OTC: The coactiv+™ Antimicrobial Wound Gel is indicated for management of minor lacerations, minor burns (1st degree burns) and abrasions for adult populations.
    Device Description
    The coactiv+™ Antimicrobial Wound Gel is a white, odorless hydrogel that provides a moist wound environment conducive to wound healing. The coactiv+™ Antimicrobial Wound Gel provides preservative properties through an antimicrobial (PHMB) to help inhibit microbial colonization within the gel during shelf storage. Chronic wounds are known to contain non-viable tissue. The coactiv+™ Antimicrobial Wound Gel can facilitate debridement through a moist wound environment. The coactiv+™ Antimicrobial Wound Gel contains water, Poloxamer 407, Glycerol, Trisodium citrate, PHMB (0.1% w/w), Citric acid, Disodium EDTA. The coactiv+™ Antimicrobial Wound Gel dressing will be supplied in 0.7 oz. (21 g) white/opaque polypropylene (19 x 100 mm) screw cap tubes. The device will be available as both a Rx and OTC product.
    Ask a Question

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