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Prescription Use: Under the supervision of a healthcare professional, the Antimicrobial Gelling Fiber Dressing with PHMB is indicated for the management of: - · Post-surgical incisions - Pressure ulcers - · Diabetic ulcers - · Venous stasis ulcers - · Donor sites - · Abrasions - · Lacerations - · Superficial and Partial thickness burns - · Dermatologic disorders - · Other wounds inflicted by trauma Over-the-Counter Use: The Antimicrobial Gelling Fiber Dressing with PHMB may be used for the management of: - · Minor abrasions - · Minor lacerations - Minor cuts - Minor scalds and bums

Antimicrobial Gelling Fiber Dressing with PHMB, is a sterile, non-woven pad or rope composed of carboxymethylcellulose (CMC) fibers, Polyhexamethylene Biguanide (PHMB), Ethylenediaminetetraacetic acid (EDTA), and a reinforcement layer (nylon) for intact removal. The dressing is soft, conformable, and highly absorbent, making it ideal for use with moderate to heavily exuding chronic and acute wounds. As wound exudate containing microorganisms is absorbed and trapped within the dressing, a gel is formed that conforms to the wound bed and anatomical contours, and aids in maintaining a moist wound environment and removing non-viable tissue and slough (autolytic debridement). This is conducive to the natural healing process. The dressing contains an active ingredient, PHMB. Based on in vitro performance data, the Antimicrobial Gelling Fiber Dressing with PHMB effectively reduces microbial colonization within the dressing for up to 7 days. The device is presented in a range of both flat/pad (160 g/m 2 and 200 g/m 2 ) and rope (160 g/m 2 ) dressings. The dressings are manufactured consistently using the same raw materials, the same manufacturing lines, follow a similar manufacturing process and utilize the same sterilization route. The sterile dressings are supplied in a range of sizes between 4in 2 (25cm 2 ) to 96in 2 (600cm 2 ).

Under the supervision of a healthcare professional, High Performance Antimicrobial Gelling Fiber with Silver can be used in the management of moderate to heavily exuding chronic and acute wounds. The antimicrobial dressing is indicated for use on the following wounds; - · Pressure ulcers (partial and full thickness) - · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - · Diabetic foot ulcers - · Surgical wounds that heal by primary intent such as dermatological and surgical incisions - · Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites - Traumatic wounds

High Performance Antimicrobial Gelling Fiber with Silver is an antimicrobial, absorbent gelling fiber dressing comprising of a non-woven pad or ribbon containing ionic silver, with a reinforcement layer to allow intact application and removal of the dressing. The dressing is sterile, soft and conformable to anatomical contours. High Performance Antimicrobial Gelling Fiber with Silver manages exudate in moderate to heavily exuding wounds and helps create a favorable environment for moist wound healing. The highly absorbent dressing absorbs exudate from the wound to form a soft gel that intimately conforms to the wound bed and aids in maintaining a moist wound environment, which is conducive to the wound healing environment and aids autolytic debridement (removal of non-viable tissue). The dressing is designed to minimize the risk of maceration and damage to newly formed tissue. High Performance Antimicrobial Gelling Fiber with Silver can be used under compression. High Performance Antimicrobial Gelling Fiber with Silver contains ionic silver, and effectively manages and suppresses colonization and proliferation of micro-organisms within the dressing for up to 7 days. High Performance Antimicrobial Gelling Fiber with Silver, when tested in vitro, has been shown to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing. The dressings are supplied sterile (gamma irradiation) in a range of sizes, ranging in area from 28cm² (4.34 in²) to 650cm² (100.75 in²). High Performance Antimicrobial Gelling Fiber with Silver is a modification of the predicate device to include updated product labelling in support of an antimicrobial product offering.

Silicone PHMB Foam Wound Dressings are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma, and as a secondary dressing for packed wounds.

The subject device, Silicone PHMB Foam Dressing, is a polyurethane foam trilaminate dressing impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment. Based on in vitro performance data, the Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria within the dressing for up to 7 days. Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against the following bacteria (MRSA, Streptococcus pyogenes, VRE, Escherichia coli, Klebsiella pneumoniae, Serratia marcescens) and yeast (Candida albicans) challenge organisms within the dressing. The perforated wound contact layer contains a gentle silicone adhesive that provides secure, non-irritating adhesion and supports nontraumatic removal during dressing changes. The device is presented in a border (adhesive) version. The dressing is supplied sterile in a range of sizes between 10.24 in2 to 64 in2.

Under the supervision of a healthcare professional, Silver High Performance Dressing can be used in the management of moderate to heavily exuding chronic and acute wounds. The dressing is indicated for use on the following wounds: - · Pressure ulcers (partial and full thickness) - · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - · Diabetic foot ulcers - · Surgical wounds that heal by primary intent such as dermatological and surgical incisions - · Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites - Traumatic wounds

Silver High Performance Dressing is a sterile dressing comprising of an absorbent non-woven fiber pad or ribbon containing ionic silver, with a reinforcement layer to allow intact application and removal of the dressing. The dressing is soft and conformable to anatomical contours. Silver High Performance Dressing manages exudate in moderate to heavily exuding wounds and helps create a favorable environment for moist wound healing. The highly absorbent dressing absorbs exudate from the wound to form a soft gel that intimately conforms to the wound bed and aids in maintaining a moist wound environment, which is conducive to the wound healing environment and aids autolytic debridement (removal of non-viable tissue). The dressing is designed to minimize the risk of maceration and damage to newly formed tissue. Silver High Performance Dressing can be used under compression. Silver High Performance Dressing contains ionic silver, and effectively manages and suppresses colonization and proliferation of bacteria and yeast within the dressing for up to 7 days. Silver High Performance Dressing , when tested in vitro, has been shown to be effective against the following four gram positive bacteria (Vancomycin- resistant enterococcus (VRE), Streptococcus mutans and Staphylococcus aureus and Methicillin - resistant staphylococcus epidermidis (MRSE)), four gram negative bacteria (Enterobacter cloacae, Klebsiella pneumonia, Serratia marcescens and Escherichia coli (E. coli)), and yeast (Candida albicans) challenge organisms within the dressing. The dressings are supplied sterile (gamma irradiation) in a range of sizes, ranging in area from 28cm² (4.34 in-) to 650cm² (100.75 in4).

Under the supervision of a healthcare professional Surgical Silver Post Operative Dressing may be used in the management of post operative surgical wounds healing by primary intent, and as an effective barrier to bacterial penetration.

The subject device, Surgical Silver Post Operative dressing, is a sterile dressing comprising of an absorbent non woven pad containing an ionic silver. This centered silver pad is secured between two layers of hydrocolloid; the outer hydrocolloid layer incorporates a breathable waterproof film. The inner layer of hydrocolloid forms a windowed self adhesive skin contact layer, which adheres to healthy skin, minimizes trauma on removal and assists in minimizing leakage. As wound fluid is absorbed the dressing forms a gel, this helps maintain a moist environment. A moist wound environment has been shown to be conducive for wound healing. The non-woven pad gelling properties allow intact removal without damage to the closure system e.g. sutures. Based on in vitro performance data, the Surgical Silver Post Operative dressing provides a barrier to bacterial penetration through the dressing and the silver component prevents colonization and proliferation of bacteria within the dressing for up to 7 days. Surgical Silver Post Operative dressings, when tested in-vitro have been demonstrated to be efficacious, achieving ≥4 log reduction within the dressing including multiple re-inoculations against three gram positive (MRSA, MRSE, VRE) bacteria, three gram negative bacteria ( Escherichia coli, Klebsiella pneumonia, Pseudomona areuginosa ) and yeast ( Candida albicans ) challenge organisms. The dressings are supplied sterile (gamma irradiation) in a range of sizes between 14 in 2 to 49 in 2 .

PHMB Foam Wound Dressings are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing for packed wounds.

The subject device, PHMB Foam Wound Dressing, is a polyurethane foam impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment. Based on in vitro performance data, the PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria within the dressing for up to 7 days. PHMB Foam dressing, when tested in-vitro has demonstrated to be effective against the following three gram positive bacteria (MRSA, MRSE, VRE), three gram negative bacteria (Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa) and two yeast (Candida albicans, Rhodotorula mucilaginosa) challenge organisms within the dressing. The device is available in Non-border (non-adhesive) and Border (adhesive) versions. The dressing is supplied sterile in a range of sizes between 4 in squared to 64 in squared.

PHMB Foam Wound Dressings are indicated for use in the temporary management (<24 hours) of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions , lacerations, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

The subject device, PHMB Foam Wound Dressing, is a polyurethane foam impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment. Based on in vitro performance data, the PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria within the dressing while in use (<24 hours). PHMB Foam dressings, when tested in-vitro have been demonstrated to be effective against the following three gram positive bacteria, three gram negative bacteria and two yeast challenge organisms within the dressing: MRSA, MRSE, VRE, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Candida albicans and Rhodotorula mucilaginosa . The device is presented in Non-border (non-adhesive) and border (adhesive) versions. The dressing is supplied sterile in a range of sizes between 4 in squared to 64 in squared .

Advanced Medical Solutions Ltd's Silver Foam Wound Dressings are indicated for moderately to heavily exuding, partial to full thickness wounds, including: pressure ulcers; leg ulcers; diabetic foot ulcers; graft wounds and donor sites; skin tears; first and second-degree burns; surgical wounds; lacerations and abrasions.

(Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings are sterile, extremely absorbent, conformable, and semi-permeable to moisture vapour, and assist in maintaining a moist environment for optimal wound healing. (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings contain nominally 1% ionic silver (silver sodium hydrogen zirconium phosphate); the action of which protects the dressing from bacterial colonisation, and provides an effective barrier to bacterial penetration. The antimicrobial properties of the dressing are effective for up to 7 days, as demonstrated in vitro, against bacterial and fungal strains known to be detrimental to wound healing, such as; Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, Streptococcus pyogenes, Staphylococcus epidermidis, MRSA (Methicillin resistant Staphylococcus aureus) MRSE (Methicillin resistant Staphylococcus epidermidis), and VRE (Vancomycin resistant Enterococcus faecium). The antibacterial effect in the (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings supports the reduction of odour caused by microorganisms absorbed in wound exudate. (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings may be used with a compression bandage.

The Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including: - Post-operative wounds . - . Trauma wounds - . Leq Ulcers - Pressure Ulcers . - Diabetic Ulcers . - Graft and donor sites . Silver Alginate II Dressing is indicated for external use only

The dressing is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver, which absorbs wound exudate and releases silver ions in the presence of wound fluid. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to four (4) days, based on in vitro laboratory testing. Odour reduction results from the antibacterial effect in the dressing. The dressing is an effective barrier to penetration by microorganisms. The dressing has a off-white appearance, and is available in various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm, 10cm x 20cm flat dressings; 2.7cm x 30cm, and 3cm x 44cm flat rope dressings; and 30cm x 2g rope dressings). The flat dressings are packaged in pouches, and the flat rope and rope dressings are packaged in a blister pack.

Advanced Medical Solutions Ltd's Antimicrobial Alginate. Dressing is an effective barrier to bacterial penetration, The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.

Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing is a sterile, non-woven pad composed of a high G (quluronic acid) alginate, carboxymethylcellulose (CMC) and silver coated nylon fibres. The sustained release of silver creates a favourable environment by protecting the dressing from bacterial contamination. The dressing absorbs exudate, maintains a moist wound healing environment and allows intact removal. The dressing has a light grey appearance, and is available in various sizes (5cm x 5cm, 11cm x 11cm, 10cm x 20cm flat dressings and 2.5cm x 30.5cm rope). The flat dressings are packaged in pouches, and the rope is packaged in a blister pack.