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510(k) Data Aggregation

    K Number
    K143017
    Device Name
    Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver
    Manufacturer
    LABORATOIRES URGO
    Date Cleared
    2015-08-07

    (291 days)

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

    LABORATOIRES URGO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Urgoclean Ag. Antibacterial Absorbent Wound Dressing with Silver is indicated to manage exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, dermatological); partial thickness burns; traumatic wounds; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided. The dressing also provides an antibiotic barrier for bacterial penetration of the dressing, which may help reduce infection.
    Device Description
    Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver is a sterile nonwoven highly absorbent pad coated with a silver containing soft-adherent lipido-colloid layer on the dressing/wound interface. In contact with body fluids (exudates, slough) it forms a gel creating a moist environment, which allows for an easy removal of the dressing with little or no damage to healing tissues, leading to no or minor pain. It is supplied sterile in an individual pouch.
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    K Number
    K123219
    Device Name
    URGOCLEAN ABSORBENT WOUND DRESSING
    Manufacturer
    LABORATOIRES URGO
    Date Cleared
    2013-03-18

    (154 days)

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

    LABORATOIRES URGO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Urgoclean Absorbent Wound Dressing is indicated to manage all exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological); partial thickness burns; management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided.
    Device Description
    Urgoclean Absorbent Wound Dressing is a sterile non-woven highly absorbent pad coated with a soft-adherent lipido-colloid layer on the dressing/wound interface. In contact with body fluids (exudates, slough) it forms a gel creating a moist environment, allowing a one piece and painless removal. It is supplied sterile in an individual pouch.
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    K Number
    K100429
    Device Name
    URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
    Manufacturer
    LABORATOIRES URGO
    Date Cleared
    2010-06-11

    (115 days)

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

    LABORATOIRES URGO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The barrier functions of Urgocell Ag, antimicrobial wound dressing with silver, may help reduce infection in moderately to high exuding partial and full thickness wounds, including decubitus ulcers, venous static ulcers, diabetic ulcer, first and second degree burns, donor and graft sites.
    Device Description
    Urgocell® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non-occlusive, antimicrobial absorbent dressing, composed of 3 layers: - in contact with the wound, a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly and silver sulphate (3.22 mg/sq.in) - a non-sensitising, super-absorbent polyurethane foam pad, - a protective, semi-permeable polyurethane backing.
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    K Number
    K100430
    Device Name
    URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
    Manufacturer
    LABORATOIRES URGO
    Date Cleared
    2010-06-11

    (115 days)

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

    LABORATOIRES URGO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The barrier functions of Urgotul Ag, antimicrobial wound dressing with silver, may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites.
    Device Description
    Urgotul® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non-occlusive, antimicrobial hydrocolloid wound contact dressing, composed of a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly and silver (2.25 mq/sq.inch).
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    K Number
    K062559
    Device Name
    URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
    Manufacturer
    LABORATOIRES URGO
    Date Cleared
    2007-01-29

    (152 days)

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

    LABORATOIRES URGO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The barrier functions of Urgocell® Ag, antimicrobial wound dressing, may help reduce infection in moderately to high exuding partial and full thickness wounds including decubitus ulcers, venous stasis ulcers , diabetic ulcers , first and second degree burns, donor and graft sites.
    Device Description
    Urgocell® Ag wound dressing is a sterile, antimicrobial absorbent wound contact dressing with silver. Urgocell® Ag wound dressing is non-occlusive and non-adhesive for painless removal. Urgocell® Ag is composed of three layers : - in contact with the wound, a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver, - a non-sensitising, super-absorbent polyurethane foam pad, - - a protective, semi-permeable polyurethane backing. -
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    K Number
    K061220
    Device Name
    URGOTUL AG
    Manufacturer
    LABORATOIRES URGO
    Date Cleared
    2006-07-27

    (87 days)

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

    LABORATOIRES URGO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The barrier functions of Urgotul® Ag Antimicrobial Wound Dressing may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites.
    Device Description
    Urgotul® Ag wound dressing is a sterile, antimicrobial hydrocolloid wound contact dressing with silver. Urgotul® Ag wound dressing is non-occlusive and non-adhesive for painless removal. Urgotul® Ag is composed of a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver.
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    K Number
    K974348
    Device Name
    ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING
    Manufacturer
    LABORATOIRES URGO S.A.
    Date Cleared
    1998-02-13

    (86 days)

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

    LABORATOIRES URGO S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Algoplaque Film Extra Thin Hydrocolloid Dressing is a topical wound dressing that is intended for the local management of superficial, dry to lightly-exudating wounds, including pressure sores, dermal ulcers, post-operative wounds or suture sites, and abrasions and lacerations. Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as protective skin coverings. Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on third degree burns.
    Device Description
    ALGOPLAQUE FILM is a flexible, semiocclusive, topical wound dressing that consists of a polyurethane backing sheet and a hydrocolloid layer. The hydrocolloid layer interacts with wound exudate - liquifying into a soft gel. This gel enables the dressing to be removed with minimal trauma to the underlying tissues.
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    K Number
    K970518
    Device Name
    ALGOPLAQUE HYDROCOLLOID DRESSING
    Manufacturer
    LABORATOIRES URGO S.A.
    Date Cleared
    1997-03-21

    (38 days)

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

    LABORATOIRES URGO S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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