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510(k) Data Aggregation

    K Number
    K983303
    Device Name
    INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS
    Manufacturer
    INNOVATIVE TECHNOLOGIES LTD.
    Date Cleared
    1998-12-09

    (79 days)

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

    INNOVATIVE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Innovative Technologies Hydrucolloids & Intelligent Hydrocolloids can be used for the management of wounds including, minor scalds and burns, superficial wounds such as abrasions, lacerations and minor cuts and as a protective dressing for such uses as minor blisters. This wound dressing may also bo used under the care of a health care professional for such wounds as, partial - full thickness wounds i. o. artorial ulcers, venous ulcers and diabetic ulcers, post operative surgical wounds. donor sites. If at any time you are unsure of the above conditions or the type of wound consult a health care professional. Discontinue use if any infection of the wound is suspected and seek guidance from a health care professional
    Device Description
    Highly floxible and conformable gol formula dressings, which absorb wound exudate producing a soft, gel mass which allows pasy removal of the dressing roducing the potential for delicate peri- wound tissue damage during dressing changes. Innovative Technologies Intelligent wound dressings utilize an intelligent film which allows moisture to transpire the hydrocolloid whilst providing a barrier to water and bacteria
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    K Number
    K982234
    Device Name
    AL-GEN CALCIUM ALGINATE DRESSING
    Manufacturer
    INNOVATIVE TECHNOLOGIES LTD.
    Date Cleared
    1998-09-08

    (75 days)

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

    INNOVATIVE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Innovative Technologies Calcium Alginate dressings are intended for use under the guidance of a health care professional on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds Donor sites Post-operative wounds Trauma wounds Dermal lesions And for OTC use on wounds such as, abrasions, lacerations, minor cuts and grazes, minor scalds and burns. They are also intended to help control minor bleeding.
    Device Description
    These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist wound environment.
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    K Number
    K982638
    Device Name
    3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214
    Manufacturer
    INNOVATIVE TECHNOLOGIES LTD.
    Date Cleared
    1998-08-21

    (23 days)

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

    INNOVATIVE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg: - Pressure ulcers Arterial Ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.
    Device Description
    These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.
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    K Number
    K981753
    Device Name
    INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING
    Manufacturer
    INNOVATIVE TECHNOLOGIES LTD.
    Date Cleared
    1998-06-30

    (43 days)

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

    INNOVATIVE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on wounds including: . Minor scalds and burns Superficial Wounds such as Abrasions, Laccrations, and cuts t This wound dressing may be also used under the care of a health care professional for such wound as, Pressure sores, post operative surgical wounds, donor sites, trauma wounds and dermal Icsions. And for such uses as a IV site and us a secondary fixation device for other wound care products such as alginates, gels and foams used for diabctic ulccrs.
    Device Description
    Innovative Technologies Transparent & Intelligent Film Wound Dressings, are conformable, sterile wound dressings intended to provide a moist environment ideally suited for wound management. In particular for partial thickness wounds. Innovative Technologies Transparent Film dressings act as a semi occlusive barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing. The Innovative Technologies Intelligent wound dressings utilize an intelligent film to enhance product performance. The semi occlusive dressing acts as a barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing.
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    K Number
    K980989
    Device Name
    3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING
    Manufacturer
    INNOVATIVE TECHNOLOGIES LTD.
    Date Cleared
    1998-05-27

    (72 days)

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

    INNOVATIVE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.
    Device Description
    These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.
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    K Number
    K980097
    Device Name
    FLEXIGEL-G HYDROGEL WOUND DRESSING
    Manufacturer
    INNOVATIVE TECHNOLOGIES LTD.
    Date Cleared
    1998-03-04

    (51 days)

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

    INNOVATIVE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of partial to full thickness wounds e.g.: - · Pressure Ulcers - · Venous Stasis Ulcers - · Diabetic Ulcers - · 1* and 2nd Degree Burns - · Surgical Wounds - · Trauma Wounds - · Dermal Lesions (Cuts, abrasions, etc) FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of wounds such as: - · Superficial cuts - · Abrasions - · Lacerations - Minor scalds - Minor bums - Minor skin irritations
    Device Description
    FlexiGel-G Amorphous Hydrogel Wound Dressing, is a clear, non-adherent, amorphous gel provided as a sterile, primary wound dressing. FlexiGel-G Amorphous Hydrogel Wound Dressing encourages natural debridement through autolysis by gently rehydrating necrotic tissue and is intended to provide a moist healing environment ideally suited for the management of partial to full thickness wounds. FlexiGel-G Amorphous Hydrogel Wound Dressing is supplied sterile in single use pouches or tubes.
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    K Number
    K973855
    Device Name
    IT HYDROCOLLOID WITH ZINC
    Manufacturer
    INNOVATIVE TECHNOLOGIES LTD.
    Date Cleared
    1997-12-01

    (53 days)

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

    INNOVATIVE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Innovative Technologies' Hydrocolloid with Zinc Wound Dressings may be used for the management of wounds including: - Partial full thickness wounds, ie. arterial, venous, diabetic ulcers - Post-operative surgical wounds - Superficial burns (1st & 2nd degree) - Donor Sites - Trauma Wounds - Dermal Lesions - Protective dressing
    Device Description
    Innovative Technologies' Hydrocolloid with Zinc Wound Dressings is a combination of two products with existing 510(k)s: 510(k) #K951499, Dermagran-B™ Hydrophilic Wound Dressing manufactured by Derma Sciences, and 510(k) #K971126, Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressing. Innovative Technologies' Hydrocolloid with Zinc Wound Dressings are highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds. The low profile of the dressing allows for ease in the use of pressure garments and normal clothing. The hydrocolloid dressing may be left in place until the exuding phase is complete. The wound may then be covered with a breathable polyurethane film such as Innovative Technologies' Film Wound Dressing 510(k) #K9204008 which protects the new tissue from mechanical trauma and maceration. Dressings are supplied sterile in single use blisters / pouches. Product is gamma irradiated in accordance with EN 552, JEN556, and ANSI / AAMI / ISO11137-1994, Sterilisation Of Health Care Products - Requirements For Validation and Routine Control - Radiation Sterilisation, 3rd Edition, Method 1 for dosimetric release with a sterility assurance level of 10^-6.
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    K Number
    K973312
    Device Name
    TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
    Manufacturer
    INNOVATIVE TECHNOLOGIES LTD.
    Date Cleared
    1997-10-22

    (49 days)

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

    INNOVATIVE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on partial thickness wounds including: - Pressure sores - . Superficial burns - Abrasions - . Lacerations - . Post-operative surgical wounds - . Donor Sites - . Trauma Wounds - Dermal Lesions - IV Sites . - Fixation device ●
    Device Description
    Innovative Technologies' Transparent Film & Intelligent Film Dressings are conformable, sterile wound dressings intended to provide a moist healing environment for partial thickness wounds, eg. pressure sores, abrasions, lacerations, donor sites and superficial burns. The dressings may also be used for IV sites or as secondary fixation devices for products such as alginates, gels and foams used for venous stasis and diabetic ulcers. Dressings are supplied sterile in single use blister packs.
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    K Number
    K973283
    Device Name
    ALGINATE/ZINC WOUND DRESSING
    Manufacturer
    INNOVATIVE TECHNOLOGIES LTD.
    Date Cleared
    1997-10-21

    (49 days)

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

    INNOVATIVE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Innovative Technologies Alginate / Zinc Wound Dressings may be used for the management of moderate to heavily exuding partial to full thickness wounds such as: - Pressure Ulcers . - Arterial Ulcers .. ● - . Venous Ulcers - . Diabetic Ulcers - . l st & 2nd Degree Burns - Donor Sites . - . Trauma Wounds - Dermal Lesions
    Device Description
    Innovative Technologies' Alginate / Zinc Wound Dressings is a combination of two products with existing 510(k)s: Dermagran™ Zinc-Saline Wet Dressing manufactured by Derma Sciences, 510(k) #K913344 and Innovative Technologies' Al-Gen™ Calcium Alginate Wound Dressing, 510(k) #K953781. Innovative Technologies' Alginate / Zinc Wound Dressings is a highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds. The non-woven Alginate / Zinc fibre preparation, which includes various sizes of flat dressings and wound packing, reacts with wound exudate to form an dispersable, gelatinous, mass providing for a moist healing environment. The gel may easily be rinsed away from the wound, reducing the potential for delicate peri-wound fissue damage during dressing changes.
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    K Number
    K971126
    Device Name
    HYDROCOLLOID WOUND DRESSINGS
    Manufacturer
    INNOVATIVE TECHNOLOGIES LTD.
    Date Cleared
    1997-06-24

    (89 days)

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

    INNOVATIVE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Innovalive Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings may be used for the management of wounds including. - Partial full thickness wounds, ie artenal, venous, diabetic ulocrs . - Post-operative surgical wounds - Donor Eiles - Trauma Wounds - Dermal Lesions - Profective dressing
    Device Description
    Innovative Technologies' Hydrocolloid Wound Dressings, are highly conformable, sterile, primary wound dressings-intended to provide an environment ideally suited for chronic wound management. The dressings are soft conformable hydrocolloid preparations for heavy to light exuding partial-full thickness wounds. The hydrocolloid preparations react with wound exudate to form an gelatinous mass providing for a moist healing environment. The dressing may easily be lifted away from the wound, reducing the potential for delicate peri-wound tissue damage during dressing changes. Dressings are supplied sterile in single use blister packs.
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