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510(k) Data Aggregation

    K Number
    K133934
    Device Name
    MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)
    Manufacturer
    LINKS MEDICAL PRODUCTS, INC.
    Date Cleared
    2014-05-02

    (130 days)

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

    LINKS MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MANUKA FOAM HC wound dressings are sterile, single-use wound care dressings for use in moist wound management of: - Leg Ulcers - Pressure Ulcers - 1st and 2nd Degree Burns - Diabetic Foot Ulcers - Surgical Wounds - Trauma Wounds A moist wound environment allows autolytic debridement of necrotic tissue.
    Device Description
    MANUKA FOAM HC wound dressings are sterile, single use wound care dressings that help maintain a moist wound environment. The primary device consists of 100% Leptospermum scoparium honey from New Zealand impregnated into an absorbent foam-fiber hybrid material. One version of the product includes a polyurethane border with a silicone adhesive. Another version of the product includes a polyurethane border with an acrylic adhesive.
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    K Number
    K131796
    Device Name
    MANUKA FILL WOUND DRESSING
    Manufacturer
    LINKS MEDICAL PRODUCTS, INC.
    Date Cleared
    2014-03-14

    (269 days)

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

    LINKS MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a healthcare professional, MANUKA FILL wound dressing is indicated for the management of: > Leg Ulcers A Pressure Ulcers > 1st and 2nd Degree Burns > Diabetic Foot Ulcers > Surgical Wounds > Trauma Wounds MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue. MANUKA FILL wound dressing may be used Over-The-Counter for the management of: > Minor Abrasions > Minor Lacerations > Minor Cuts > Minor Scalds and Minor Burns MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.
    Device Description
    MANUKA FILL wound dressing is a sterile, single-use, wound care dressing that helps maintain a moist wound environment conducive to wound healing. The primary device consists of 100% Leptospermum scoparium honey from New Zealand sealed into low-density polyethylene (LDPE) tubes and sterilized using gamma irradiation.
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    K Number
    K120976
    Device Name
    MANUKA IG
    Manufacturer
    LINKS MEDICAL PRODUCTS, INC.
    Date Cleared
    2012-05-23

    (51 days)

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

    LINKS MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MANUKA IG wound dressings are sterile, single-use, wound care dressings for use in moist wound management. MANUKA IG wound dressings may be used Over-The-Counter for: - Minor Abrasions - Lacerations - Minor Cuts - Minor Scalds and Burns Under the supervision of a healthcare professional, MANUKA IG wound dressings may be used for: - Leg Ulcers - Pressure Ulcers - 1st and 2nd Degree Burns (Superficial and Partial Thickness) - Diabetic Foot Ulcers - Surgical Wounds - Traumatic Wounds
    Device Description
    MANUKA IG wound dressings are sterile, single-use wound care dressings for use in moist wound management. The primary device is Leptospermum scoparium honey from New Zealand impregnated into acetate gauze. MANUKA IG is coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum scoparium Manuka honey that is harvested and processed under controlled conditions.
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    K Number
    K121227
    Device Name
    MANUKA FILL
    Manufacturer
    LINKS MEDICAL PRODUCTS, INC.
    Date Cleared
    2012-05-23

    (30 days)

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

    LINKS MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MANUKA FILL wound dressings are sterile, single-use, wound care dressings for use in moist wound management. MANUKA FILL wound dressings may be used Over-The-Counter for: - Minor Abrasions - Lacerations - Minor Cuts - Minor Scalds and Burns Under the supervision of a healthcare professional, MANUKA FILL wound dressings may be used for: - Leg Ulcers - Pressure Ulcers - 1st and 2nd Degree Burns (Superficial and Partial Thickness) - Diabetic Foot Ulcers - Surgical Wounds - Traumatic Wounds
    Device Description
    MANUKA FILL wound dressings are sterile, single-use wound care dressings for use in moist wound management. The primary device is Leptospermum scoparium honey from New Zealand that is harvested and processed under controlled conditions. This honey is sealed into low density polyethylene tubes (LDPE) before sterilization using gamma irradiation.
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