Search Filters

Search Results

Found 9 results

510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    DERMAPHYLYX, INC.

    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
    K991920
    Device Name
    DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
    Manufacturer
    DERMAPHYLYX, INC.
    Date Cleared
    1999-08-12

    (66 days)

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

    DERMAPHYLYX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermaphylyx Hydrophilic Foam Dressing Foam Wound Dressings provide a degree of exudate absorption. They arc intended for use in the management of partial and full-thickness wounds. The following indications for use are for Prescription Use or under the direction of a health care professional: Venous stasis ulcers Diabetic ulcers Pressure sores Donor sites Burns, (superficial) Abrasions and lacerations Incisions Additionally Fenestrated dressings are intended for use in the management of surgically induced drainage sites such as: G-tubes, J-tubes, Penrose drains, chest tubes, nephrotomy tubes, and sump drains. The following indications for use are for Over-the-Counter Use: Minor Burns Minor cuts Minor abrasions Minor lacerations
    Device Description
    Dermaphylyx Hydrophilic Foam Wound Dressings are sterile, and absorptive. Dermaphylyx Hydrophilic Foam Wound Dressing is composed of a hydrophilic polyurethane foam, The product provides absorptive qualitics to assist in the management of wound drainage.
    Ask a Question
    K Number
    K991933
    Device Name
    DERMAPHYLYX FOAM ISLAND DRESSING
    Manufacturer
    DERMAPHYLYX, INC.
    Date Cleared
    1999-07-30

    (52 days)

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

    DERMAPHYLYX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K991608
    Device Name
    DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
    Manufacturer
    DERMAPHYLYX, INC.
    Date Cleared
    1999-07-20

    (71 days)

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

    DERMAPHYLYX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound. The following Indications are for Prescription Use or under the direction of a health care professional: - Venous ulcers - Diabctic ulcers - Pressure ulcers - Ancrial ulcers - Superficial burns - Abrasions and laccrations - Donor sites - Postoperative wounds The following Indications are for Over-the-Counter Usc: - Abrasions - Minor Burns - Minor Cuts - Minor Laccrations
    Device Description
    Dermaphylyx Calcium Alginate Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of calcium alginate fibers fabricated into a felt or rope configuration. Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a gel/fiber mat which provides an environment conducive to moist wound healing. The formation of the gel/fiber mat facilitates trauma free removal from the wound.
    Ask a Question
    K Number
    K991609
    Device Name
    DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
    Manufacturer
    DERMAPHYLYX, INC.
    Date Cleared
    1999-07-20

    (71 days)

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

    DERMAPHYLYX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. They are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound, The following Indications are for Prescription Use or under the direction of a health care professional: Venous ulcers Diabetic ulcers Pressure ulcers Arterial ulcers Superficial burns Abrasions and lacerations Donor sites Incisions The following Indications are for Over-the-Counter Use: Abrasions Minor Burns Minor Cuts Minor Lacerations
    Device Description
    Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of Absorbent fibers fabricated into a felt or rope configuration. Dermaphylyx Absorbent Fiber Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a fiber mat which provides an environment conducive to moist wound healing. The fiber mat facilitates traums free removal from the wound.
    Ask a Question
    K Number
    K991061
    Device Name
    DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
    Manufacturer
    DERMAPHYLYX, INC.
    Date Cleared
    1999-06-28

    (90 days)

    Product Code
    NAE, MGQ
    Regulation Number
    878.4022
    Why did this record match?
    Applicant Name (Manufacturer) :

    DERMAPHYLYX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding. The following Indications are for Prescription Use or under the direction of a health care professional: - Venous ulcers - Diabctic ulcers - Pressure ulcers - Arterial ulcers - Superficial burns - Abrasions and lacerations - Donor sites - Postoperative wounds The following Indications are for Over-the-Counter Use: - Abrasions - Minor Burns - Minor Cuts - Minor Lacerations
    Device Description
    Dermaphylyx Calcium Alginate Wound Dressings consist of calcium alginate fibers fabricated into felt and rope configurations. Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound cxudate. During the absorption of exudate the dressing forms a gel/liber mat. The formation of the gel/fiber mat may help facilitate removal from the wound.
    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?
    Applicant Name (Manufacturer) :

    DERMAPHYLYX, INC.

    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
    K990891
    Device Name
    DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING
    Manufacturer
    DERMAPHYLYX, INC.
    Date Cleared
    1999-05-27

    (71 days)

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

    DERMAPHYLYX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermaphylyx Hydrocolloid 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: Venous stasis ulcers Diabetic ulcers Pressure sores Blisters Superficial burns Abrasions and laccrations Donor sites The following Indications are for Over-the-Counter Use: Abrasions Minor Burns Minor Cuts Minor Lacerations Blisters
    Device Description
    Dermaphylyx Hydrocolloid Wound Dressings are sclf-adhesive, semi-occlusive and absorptive. The wound contact surface is composed of a hydrocolloid adhesive. A second layer consists of a polyurcthane film/foam. The product provides a barrier to exogenous water and dirt 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?
    Applicant Name (Manufacturer) :

    DERMAPHYLYX, INC.

    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

    Page 1 of 1