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The Derma Sciences Medihoney Wound Gel helps maintain a moist environment. Moist wound environment was shown to be conducive to wound healing. For over the counter use, Medihoney Wound Gel may be used for: - minor abrasions - lacerations - minor cuts - minor scalds and burns. Under the supervision of a healthcare professional, Medihoney Wound Gel helps maintain a moist environment. Moist wound environment was shown to be conducive to wound healing and are indicated for non-draining to moderately exuding wounds. The Medihoney Wound Gel is intended for the management of the following: - diabetic foot ulcers - leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - pressure ulcers / sores (partial and full thickness) - 1st and 2nd degree partial thickness burns - donor sites, and traumatic and surgical wounds.

The primary component of the Medihoney Wound Gel is Active Leptospermum Honey. The purpose of this 510(k) is to obtain clearance for a slightly modified version of the Derma Sciences Medihoney Wound Gel Dressings subject of K101793. The original Medihoney Gel Dressings contain Active Manuka Honey, Myristate, and Plantacare. The proposed Medihoney Gel Dressings contains a slightly different formulation than the original Medihoney Gel Dressings in that Sodium Benzoate has been added as a preservative to the formulation. Due to the limitations in hermetically sealing the Wound Gel jar lids, this product will be Gamma Irradiated at 25-45kGy dosage, which will help reduce the product bioburden. However this product will not be claimed sterile. Gamma Irradiation will aid in reducing the product bioburden and the preservative Sodium Benzoate will act as a preservative within the gel.

Medihoney Calcium Alginate Dressing with Active Leptospermum Honey are indicated for the management of moderate to heavily exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the management of the following: - · Diabetic foot ulcers - · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - · Pressure ulcers/sores (partial and full thickness) - · 1st and 2nd degree partial thickness burns - donor sites - · traumatic and surgical wounds Medihoney Adhesive and Non-Adhesive Honeycolloid Dressings with Active Leptospermum Honey are indicated for the management of light to moderately exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the following: - · Diabetic foot ulcers - · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - · Pressure ulcers/sores (partial and full thickness) - · 1st and 2nd degree partial thickness burns - donor sites - · traumatic and surgical wounds Medihoney Dressings with Active Leptospermum Honey are indicated for the management of light to moderately exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the management of the following: - · Diabetic foot ulcers - · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - · Pressure ulcers/sores (partial and full thickness) - · 1st and 2nd degree partial thickness burns - donor sites - · traumatic and surgical wounds Medihoney Gel Dressing with Active Leptospermum Honey are indicated for the management of light to moderately exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the management of the following: - Diabetic foot ulcers - · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - · Pressure ulcers/sores (partial and full thickness) - · 1st and 2nd degree partial thickness burns - donor sites - traumatic and surgical wounds The Medihoney Adhesive and Non-Adhesive Hydrogel Colloidal Sheet with Leptospermum Honey are indicated for the management of non-draining to lightly exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the following: - Diabetic foot ulcers - · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - · Pressure ulcers/sores (partial and full thickness) - · 1st and 2nd degree partial thickness burns - donor sites - traumatic and surgical wounds

The primary component of the Medihoney Family of Dressings is Active Manuka Honey. The composition, formulation and materials of the Medihoney Dressings are described below. The Medihoney Family of Dressings are provided sterile to the user and are NOT required to be sterilized. Calcium Alginate Dressing with Active Leptospermum Honey: comprised of 95% Active Manuka Honey and 5% Calcium Alginate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment that aids and supports the autolytic debridement. Sizes: ¾"x 12"/2"x2"/4"x5" Adhesive/Non-Adhesive Honevcolloid Dressing with Active Leptospermum Honey: comprised of 80% Active Manuka Honey and 20% Sodium Alginate Powder (hydrocolloid sheet) As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment that aids and supports the autolytic debridement. Sizes: 2"x2,"/4"x5" (non-adhesive)/2"x2"/4.5"x4.5" (adhesive) Dressing with Active Leptospermum Honey: comprised of 100% Active Manuka Honey and are sterile wound dressings for use in moist wound management. The Medihoney Dressing comprised of 100% Active Manuka Honey helps to maintain a moist environment. The Medihoney Dressing with Active Manuka Honey is offered in several sizes including 0.5, 1, and 1.5 oz. tube sizes. Gel Dressing with Active Leptospermum Honey: comprised of 80% Active Manuka Honey, 15% Myristyl Myristate and 5% Plantacare 810. As wound exudate is absorbed, the dressing forms a gel, which assists in maintaining a moist environment that aids and supports autolytic debridement. The Medihoney Gel Dressings are offered in 0.5 and 1.5 oz sizes Adhesive/Non-Adhesive Hydrogel Colloidal Sheet with Leptospermum Honey: comprised of 63% Leptospermum Honey and hydrogel both with and without an adhesive border. As wound exudate is absorbed, the dressing forms a gel, which assists in maintaining a moist environment that aids and supports autolytic debridement. The Medihoney Hydrogel Sheet Dressings are offered in 1.8'x1.8"/2.4"x2.4"/4.3"x4.3"/8"x12" (adhesive) 2.8"x2.8"/4.5"x4.5" (non-adhesive)

The Derma Sciences Medihoney Hydrogel Sheet Dressings (Adhesive and Non-adhesive) with Leptospermum Honey provides a moist environment conducive to wound healing and are indicated for non-draining to lightly exuding wounds. For over the counter use, Medihoney Hydrogel Sheet Dressings (Adhesive and Nonadhesive) with Leptospermum Honey may be used for: - minor abrasions - minor cuts - minor scalds - minor burns Under the supervision of a healthcare professional, The Derma Sciences Medihoney Hydrogel Sheet Dressings provide a moist environment conducive to wound healing and are indicated for non-draining to lightly exuding wounds. The Medihoney Hydrogel Sheet Dressings are intended for the management of the following: - diabetic foot ulcers - leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - pressure ulcers / sores (partial and full thickness) - 1st and 2nd degree partial thickness burns - donor sites, and traumatic and surgical wounds

Derma Sciences Medihoney Hydrogel Sheet Dressings with Leptospermum Honey are sterile, single-use wound care dressings for use in moist wound management. The dressings are comprised of 63% Leptospermum Honey and hydrogel both with and without an adhesive border. The Derma Sciences Medihoney Hydrogel Sheet Dressings with Leptospermum Honey are offered in the following sizes: 2 ¼" x 2 ¾", 4 1/3" x 4 1/3", 6" x 9", 4 1/3" x 4 1/3" (adhesive border), 6" x 6" (adhesive border).

The Derma Sciences Medihoney Gel Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. For over the counter use, Medihoney Gel Dressings with Active Manuka Honey may be used for: - minor abrasions - lacerations - minor cuts - minor scalds and burns Under the supervision of a healthcare professional, The Derma Sciences Medihoney Gel Dressings provide a moist environment conducive to wound healing and are indicated for light to moderate exuding wounds. The Medihoney Gel Wound Dressings are intended for the management of the following: - diabetic foot ulcers - leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - pressure ulcers / sores (partial and full thickness) - 1st and 2nd degree partial thickness burns - donor sites, and traumatic and surgical wounds.

Derma Sciences Medihoney Gel Dressings with Active Manuka Honey are sterile, wound care dressings for use in moist wound management. The Derma Sciences Medihoney Gel Dressing with Active Manuka Honey is offered in 10, 20, and 25 oz tubes sizes. The dressings are comprised of honey an emulsifier and a surfactant. The proposed Medihoney Gel Dressing with Active Manuka Honey contains Active Manuka Honey. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment that aids supports the autolytic debridement for optimal wound healing. The proposed Medihoney Gel Wound Dressings with Active Manuka Honey are comprised of 80% Active Manuka Honey, 15% Myristyl Myristate and 5% Plantacare 810 compared to the parent Medihoney Primary Dressings which are comprised of 100% honey, 80% Active Manuka Honey and 20% sodium alginate powder or 95% w/w Active Manuka Honey and 5% w/w Calcium Alginate. The addition of the Myristyl Myristate and Plantacare 810 increases the viscosity of the gel which helps to improve adherence to the wound bed.

For over the counter use, MEDIHONEY™ APIMED, PRIMARY and 100% HONEY Dressings with Active Manuka Honey may be used for: - minor abrasions - lacerations - minor cuts - minor scalds and burns Under the supervision of a healthcare professional, The Derma Sciences Apimed (MediHoney) Dressings are all indicated for moderate to heavily exuding wounds. The Medihoney Primary Wound Dressings are indicated for lightly to moderately exuding wounds. The Medihoney 100% Honey Dressings are indicated for nonexuding to moderately exuding wounds. All of the Medihoney Wound Dressings are intended for the management of the following: - diabetic foot ulcers - leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - pressure ulcers / sores (partial and full thickness) - 1st and 2nd degree partial thickness burns - donor sites and traumatic and surgical wounds.

The Derma Sciences OTC Medihoney Dressings (APIMED, Medihoney Primary and Medihoney 100% Gel) with Active Manuka Honey are designed to provide a moist environment conducive to wound healing and are indicated abrasions, minor burns, minor cuts and minor lacerations. The Derma Sciences OTC Medihoney Dressings with Active Manuka Honey are sterile, single-use wound care dressings for use in moist wound management. The Derma Sciences OTC Medihoney APIMED Primary Dressings with Active Manuka Honey are offered in several sizes including the following: 2x2, 4x4, % x 12, The OTC Medihoney Primary Dressings with Active Manuka Honey are offered in 1.5" x 2", 2" x 2", 4" x 5", and 2"x3" sizes and are offered both with and without an adhesive backing. The OTC Medihoney 100% Honey Gel Dressings are offered in .5, 1, and 1.5 oz. sizes. The proposed OTC Medihoney Dressings with Active Manuka Honey are identical in fundamental technology and very similar in indications to the parent API-MED Active Manuka Honey Dressings described in K053095, the Medihoney Primary Dressings with Active Manuka (Leptospermum) Honey in a hydrocolloid sheet (K072956) and the Medihoney Active Manuka (Leptospermum) 100% Honey The dispensed from a tube pending 510(k) premarket notification (K080315). modifications made to the API-MED, Medihoney Primary and Medihoney 100% Gel Active Manuka Honey Dressings to produce the Derma Sciences OTC Medihoney Dressings with Active Manuka Honey are limited to a slight change in indications and over the counter use. The formulation and function are identical to that described in the original 510(k)'s.

The Derma Sciences Medihoney Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and is indicated for the management of light to moderately exuding wounds such as: - . diabetic foot ulcers - leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed . etiology) - . pressure ulcers / sores (partial and full thickness) - 1st and 2nd degree partial thickness burns ◆ - . donor sites, and traumatic and surgical wounds.

Derma Sciences Medihoney Dressing with Active Manuka Honey are sterile, wound care dressings for use in moist wound management. The Derma Sciences Medihoney Dressing with Active Manuka Honey are offered in several sizes including .5, 1, and 1.5 oz. sizes. The proposed Medihoney Dressing with Active Manuka Honey contains Active Manuka Honey. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment that aids supports the autolytic debridement for optimal wound healing.

The Derma Sciences Medihoney Primary Dressing with Active Manuka Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds such as: - . diabetic foot ulcers - leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed . etiology) - pressure ulcers / sores (partial and full thickness) . - . 1st and 2nd degree partial thickness burns - donor sites, and traumatic and surgical wounds. .

Derma Sciences Medihoney Primary Dressings with Active Manuka Honey are sterile, single-use wound care dressings for use in moist wound management. The Derma Sciences Medihoney Primary Dressings with Active Manuka Honey are offered in several sizes including 2" x 2", ¾ x 12", 4" x 4" and 4" x 5". The dressings are comprised of honey and sodium alginate. The proposed Medihoney Primary Dressing with Active Manuka Honey contains Active Manuka Honey. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment that aids supports the autolytic debridement for optimal wound healing, and allows intact removal.

Dermagran® Wound Management System (Systerm), when applied to the wound provides a wound cleanser and primary cover and/or filler for wound deficiencies. The System absorbs exudate and creates a moist, mildly acidic wound environment. The moist environment created by the System is conducive to wound healing and autolytic debridement. The System is useful in the management of various skin injuries which result in lacerations, abrasions, post-surgical wounds, skin ulcerations (pressure, diabetic, venous stasis), surgical incisions, and partial thickness burns.

Dermagran Wound Management System (System) contains two components, Dermagran Wound Cleanser with Zinc and Dermagran-B Hydrophilic Ointment. The Systerm, when applied to the wound provides a wound cleanser and primary cover and/or filler for wound deficiencies. The System absorbs exudate and creates a moist, mildly acidic wound environment. The moist environment created by the System is conducive to wound healing and autolytic debridement. The System is useful in the management of various skin injuries which result in lacerations, abrasions. post-surgical wounds, skin ulcerations (pressure, diabetic, venous stasis), surgical incisions, and partial thickness burns.