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510(k) Data Aggregation

    K Number
    K162017
    Device Name
    Ross Ru Wound Dressing Gel
    Manufacturer
    BIOTD, S.A.
    Date Cleared
    2017-04-20

    (273 days)

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

    BIOTD, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ross Ru Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.
    Device Description
    Ross Ru is a wound dressing gel that helps maintain a moist wound environment that is conducive to healing, by either absorbing or donating the moisture and wound exudates. Ross Ru Wound Dressing Gel is supplied in a collapsible low density polyethylene tube sealed at one end and fitted with a dispensing orifice at the other end accessible by the removal of its screw cap.
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    K Number
    K141637
    Device Name
    SPB SKIN EMULSION
    Manufacturer
    BIOTD, S.A.
    Date Cleared
    2015-06-03

    (349 days)

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

    BIOTD, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prescription Use: As a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allerge contact dermatitis. SPB helps maintain a moist wound & skin environment, which is be healing process. Over-The-Counter Use: An OTC topical skin care emulsion to relieve the burning associated with many common types of skin irritation. SP helps maintain a moist wound & skin environment, which is beneficial to the healing process.
    Device Description
    SPB Skin Emulsion is a topical skin care emulsion that is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. SPB Skin Emulsion contains natural extracts to moisturize the skin.
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    K Number
    K131176
    Device Name
    ROSS RU SKIN DISCONTINUITIES
    Manufacturer
    BIOTD, S.A.
    Date Cleared
    2014-05-12

    (382 days)

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

    BIOTD, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An over-the-counter (OTC) product for topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.
    Device Description
    Ross Ru is a wound dressing gel that helps maintain a moist wound environment that is conducive to healing, by either absorbing or donating the moisture and wound exudates and may inhibit the growth of microorganisms within the dressing. Ross Ru Skin Discontinuities is supplied in a collapsible low density polyethylene tube sealed at one end and fitted with a dispensing orifice at the other end accessible by the removal of its screw cap.
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