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510(k) Data Aggregation

    K Number
    K232080
    Device Name
    Puracyn® Plus Antimicrobial Irrigation Solution
    Manufacturer
    Innovacyn, Inc.
    Date Cleared
    2024-05-31

    (323 days)

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

    Innovacyn, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Puracyn® Plus Antimicrobial Irrigation Solution is applied with irrigation to cleanse and remove debris from wounds.
    Device Description
    Puracyn® Plus Antimicrobial Irrigation Solution is a wound irrigation formula that contains hypochlorous acid as an antimicrobial preservative to inhibit the growth of micro-organisms within the solution. Puracyn® Plus Antimicrobial Irrigation Solution is supplied sterile in 1000 mL and 3000 mL flexible LLDPE bag configurations. Each bag is packaged in a sealed foil pouch.
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    K Number
    K150799
    Device Name
    Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula
    Manufacturer
    INNOVACYN, INC.
    Date Cleared
    2015-11-19

    (238 days)

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

    INNOVACYN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Over-the-Counter Use: Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel is intended for OTC use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process. For Professional Use: Puracyn® Plus Antimicrobial Hydrogel Professional Formula is intended for use by healthcare professionals to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions, as indicated below. Puracyn® Plus Antimicrobial Hydrogel Professional Formula relieves itch and pain associated with dermal irritation, sores, injuries and ulcers of dermal tissue in addition to moistening absorbent wound dressings. Puracyn® Plus Antimicrobial Hydrogel Professional Formula is indicated for the management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic and stasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.
    Device Description
    Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and the Puracyn® Plus Antimicrobial Hydrogel Professional Formula are opaque and pH balanced hydrogel dressings that are topically applied to skin and wound areas. The gel provides relief from itching and pain, and helps maintain a moist wound environment to assist with the wound healing process. The hydrogel dressings will be supplied in various packaging configurations. Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and the Puracyn® Plus Antimicrobial Hydrogel Professional Formula contain hypochlorous acid, a known antimicrobial, which serves as a preservative to inhibit the growth of microorganisms in the hydrogel.
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    K Number
    K133542
    Device Name
    PURACYN PLUS SKIN AND WOUND
    Manufacturer
    INNOVACYN, INC.
    Date Cleared
    2014-04-28

    (161 days)

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

    INNOVACYN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC: Puracyn Plus™ Skin and Wound Care is intended for the management of minor skin wounds including minor lacerations, minor abrasions, minor cuts, minor bums and intact skin, in addition to moistening and lubricating absorbent wound dressings. Professional Use: Puracyn Plus™ Skin and Wound Care is intended for use by healthcare professionals for cleansing, irrigating, moistening, and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd degree burns, stage 1 - 1V pressure ulcers, stasis ulcers, abrasions and minor skin irritations, post-surgical wounds, grafted and donor sites, in addition to moistening and lubricating absorbent wound dressings.
    Device Description
    Puracyn Plus™ Skin and Wound Care is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Puracyn Plus™ Skin and Wound Care will be supplied in food grade 4 oz. plastic PET bottles with spray inserts and caps.
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