Search Filters

Search Results

Found 40 results

510(k) Data Aggregation

    K Number
    K012995
    Device Name
    COLLATEK SHEET
    Manufacturer
    BIOCORE MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2001-10-25

    (49 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MGP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collatek Sheet may be used in the management of: - Partial and full thickness wounds - Pressure (stage 1-1V) and venous ulcers - Ulcers caused by mixed vascular etiologies - Venous stasis and diabetic ulcers - 1st and 2nd degree burns - Cuts, abrasions and surgical wounds
    Device Description
    Collatek® Shect is a stcrile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. Collatek® Sheet is packaged as a sclfadhering island dressing which is able to conform to most wound sites. Collatek® Sheet consist of a hydrocolloid sheet with a clear adherent medical tape backing on one side and a peel-off silica-coated paper on the other. It is to be used manage full and partial thickness wounds with light exudate.
    Ask a Question
    K Number
    K012997
    Device Name
    COLLATEK FOAM
    Manufacturer
    BIOCORE MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2001-10-25

    (49 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MGP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collatek Foam may be used in the management of: - Partial and full thickness wounds - Pressure (stage I-IV) and venous ulcers - Ulcers caused by mixed vascular etiologies - Venous stasis and diabetic ulcers - 1st and 2nd degree burns - Cuts, abrasions and surgical wounds
    Device Description
    Collatekto Fourn is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to manage full and partial thickness wounds with moderate to heavy exudate. Collatek® Foam is composed of two scparate layers: a collagen matrix layer and a medical grade foam layer. Collatek Foam's collagen matrix layer is made from insoluble fibrous type I bovinc collagen derived from cowhide. Collatek@ Foam's foam layer is a medical grade polyurothane fourn. Collatek® Foam will be initially available in a 4"x 4" size pad, additional sizes may be introduced at a later time.
    Ask a Question
    K Number
    K001508
    Device Name
    LASERSKIN DRESSING
    Manufacturer
    FIDIA ADVANCED BIOPOLYMERS SRL
    Date Cleared
    2001-07-25

    (436 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MGP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K990079
    Device Name
    FASTSEAL CHEST WOUND DRESSING
    Manufacturer
    GREENFIELD MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-12-23

    (346 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MGP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds. - 2. To be used on a temporary and emergency basis in the management of an open pneumothorax condition. - 3. To prevent a tension pneumothorax, and for reinflate a collapsed lung without using invasive procedures.
    Device Description
    Not Found
    Ask a Question
    K Number
    K991214
    Device Name
    SIMPLICARE TRANSPARENT WOUND DRESSING
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    1999-10-14

    (188 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MGP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SimpliCare Transparent Wound Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The SimpliCare Transparent Wound Dressing provides a barrier to viral and bacterial contaminants and other external contaminates such as urine and feces. The SimpliCare Wound Dressing is also intended to be used on IV sites or as secondary fixation device for products such as alginates, gels and foam dressings. The SimpliCare Transparent Wound Dressing is indicated for use on wounds including: - minor burns and scalds . - superficial cuts, lacerations and abrasions ● - minor irritations of the skin . This wound dressing may also be used for non-exudating to minimally exudating partial and full thickness wounds such as: - pressure ulcers . - lacerations/abrasions . - surgical incisions . - . second degree burns - donor sites . In addition, the SimpliCare Transparent Wound Dressing can be used on IV sites and as a secondary fixation device
    Device Description
    The Hollister SimpliCare Transparent Wound Dressing is a polyurethane film that is backed with a pressure sensitive acrylic adhesive. A unique closed cell foam application grid allows for easy handling of the film dressing during application to the wound sites. The Hollister Transparent Wound Dressing is designed to have a high moisture vapor transmission rate and is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Transparent Wound Dressing provides a barrier to viral and bacterial contaminates and other external contaminants such as feces and urine while the dressing remains intact without leakage. The dressing is also intended to be used on IV sites or as secondary fixation device for products such as alginates, gels, and foam dressings. The Hollister Transparent Wound Dressing is presented sterile and is available in a variety of sizes to accommodate various sizes of wounds.
    Ask a Question
    K Number
    K992302
    Device Name
    DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
    Manufacturer
    DERMAPHYLYX, INC.
    Date Cleared
    1999-09-14

    (68 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MGP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermaphylyx Skin Protectors act like an extra layer of skin. They are intended to be used in the prevention of blisters and friction burns. The following indications for use are for Prescription and Over-the-Counter Use: Dermaphylyx Skin Protectors are intended for the prevention of: - Blisters . - Friction Burns .
    Device Description
    Dermaphylyx Skin Protectors are non-sterile, self-adhesive, flexible, and absorptive. Dermaphylyx Skin Protectors act as an extra layer of skin protection. They are intended to be used in the prevention of blisters and friction burns. The skin contact surface of Dermaphylyx Skin Protectors is composed of a porous pressure sensitive adhesive. A second layer consists of a polyurethane foam. The product provides a barrier to exogenous water and dirt while maintaining breathability
    Ask a Question
    K Number
    K992005
    Device Name
    GILTECH PLUS TRANSPARENT DRESSING
    Manufacturer
    GILTECH PLUS, INC.
    Date Cleared
    1999-09-03

    (80 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MGP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Giltech Plus Transparent Dressing is indicated for the management of moderately draining wounds such as: (a) Stage I and II pressure sores (decubitus ulcers) (b) Skin tears or lacerations (c) Superficial burns and abrasions (d) Surgical wounds
    Device Description
    Transparent Dressing
    Ask a Question
    K Number
    K990875
    Device Name
    DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
    Manufacturer
    DERMAPHYLYX, INC.
    Date Cleared
    1999-05-27

    (72 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MGP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermaphylyx Film Wound Dressings are self-adhesive and semi-occlusive. They are intended for use in the management of a variety of partial and full-thickness wounds. The following Indications are for Prescription Use or under the direction of a health care professional: Dermal Ulcers Donor Sites Incisions Superficial Burns Abrasions and lacerations IV Catheter Sites The following Indications are for Over-the-Counter Use: Abrasions Minor Burns Minor Cuts Minor Lacerations Blisters As a Cover for gauze and gel bandages.
    Device Description
    Dermaphylyx Film Wound Dressings are self-adhesive and semi-occlusive. The wound contact surface is composed of a porous adhesive. A second layer consists of a polyurethane film which is waterproof and dirt proof while maintaining breathability.
    Ask a Question
    K Number
    K990438
    Device Name
    DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING
    Manufacturer
    DERMAPHYLYX, INC.
    Date Cleared
    1999-03-25

    (42 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MGP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermallex Foam Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of a variety of partial and full-thickness wounds. The following indications are for Prescription Use or under the direction of a health care professional: Burns, (electrical and chemical) Venous stasis ulcers Abrasions and lacerations Diabetic ulcers Pressure sores Incisions Burns and abrasions associated with resurfacing procedures Donor sites such as dermabrasion, chemical, and laser resurfacing Skin Tears The following indications are for Over-the-Counter Use: Abrasions Poison Ivy Sunburn Minor burns Minor cuts Minor lacerations Blisters
    Device Description
    Dormaflex™ Foam Wound Dressings are sterile, self-adhesive, and absorptive. Dennaflex provides moist wound environment characteristics and absorptive qualities of traditional therapies in a structure, which is both adhesive and conformable. The wound contact surface of Dermallex is composed of a porous adhesive. A second layer consists of a microporous polyurethane foam. The product provides a barrier and dirt while maintaining breathability
    Ask a Question
    K Number
    K984371
    Device Name
    MEPITEL NON ADHERENT SILICONE DRESSING
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Date Cleared
    1999-03-03

    (86 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MGP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mepitel is intended for the management of wounds in the granulation phase, especially painful wounds and wounds with newly formed delicate tissue such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, second degree burns, skin abrasions, lacerations, partial and full thickness grafts, and skin tears.
    Device Description
    Mepitel is a sterile wound dressing which consists of three components: a medical grade silicone gel, a polyamide tricot net, and a low density polyethylene protective release liner. The dressing is delivered sterile in single packs and is available in the following sizes: 2" x 3" (5 cm x 7.5 cm); 3" x 4" (7.5 cm x 10 cm); 4" x 8" (10 cm x 18 cm); and 9" x 12" (20 cm x 30 cm).
    Ask a Question

    Page 1 of 4