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510(k) Data Aggregation

    K Number
    K192527
    Device Name
    Rochal Antimicrobial Wound Gel
    Manufacturer
    Rochal Industries, LLC
    Date Cleared
    2020-02-07

    (147 days)

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

    Rochal Industries, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ROCHAL Antimicrobial Wound Gel is intended for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), first- and second-degree burns, partial- and full-thickness wounds, large surface area wounds, and surgical incisions. ROCHAL Antimicrobial Wound Gel is intended for the management of minor skin scrapes, minor cuts, minor lacerations, minor burns (1st degree burns), minor irritations.
    Device Description
    ROCHAL Antimicrobial Wound Gel provides a moist environment to wound surfaces. ROCHAL Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial (PHMB). ROCHAL Antimicrobial Wound Gel: - Resists microbial colonization within the dressing during shelf storage. - Provides an amorphous gel covering - Facilitates autolytic debridement through a moist wound environment. Wounds experience some level of autolytic debridement where the body's own enzymes breakdown necrotic tissue. ROCHAL Antimicrobial Wound Gel contains: Water, Poloxamer 407, Sodium Chloride, Ethylhexylglycerin, Octane-1-2-diol, Polyaminopropyl Biguanide (preservative: PHMB 0.1% w/w) Edetate disodium (EDTA), Edetate trisodium (EDTA)
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    K Number
    K182733
    Device Name
    Rochal Bioshield Silicone Film
    Manufacturer
    Rochal Industries, LLC
    Date Cleared
    2019-06-27

    (272 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rochal Industries, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rx: Bioshield Silicone Film is intended to cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions. OTC: Bioshield Silicone Film is intended to help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.
    Device Description
    Rochal Bioshield Silicone Film is a polymeric solution which forms a protective, polymer film (silicone) when applied to skin. The product is biocompatible and non-stinging. The formed silicone film is colorless, transparent, water-proof barrier, which is breathable, possessing good oxygen and moisture vapor permeability. Rochal® Bioshield Silicone Film will be supplied in a High-Density Polyethylene (HDPE), 28 mL bottles with pump spray cap.
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