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Over-The Counter Indications: Local management of superficial wounds, minor burns, abrasions and lacerations. Prescription Indications: Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds (donor and graft sites, incisions), first and second degree thermal burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites and wound drain sites. Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for decontaminated stable unroofed first and second degree mustard-induced vesicant injuries not requiring skin grafting. Silverlon® Wound Contact, Burn Contact Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Wound Contact, Burn Contact Dressings may help reduce the risk of wound infection and support the body's healing process. Silverlon® Wound Contact, Burn Contact Dressings may be used for the management of painful wounds. Silverlon® Wound Contact, Wound Burn Dressings are a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.

Silverlon Wound Contact, Burn Contact Dressings are sterile, porous, non-adherent, knitted nylon plated with 99% elemental silver oxide. Silver oxide. Silverlon Wound Contact, Burn Contact Dressings delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. Silverlon Wound Contact, Burn Contact Dressings are used as the primary wound contact layer and is placed under reticulated foam, gauze, or other wound dressings. Silverlon Wound Contact, Burn Contact Dressings are non-adherent, wound care dressings designed to be used up to seven (7) days.

Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing are multi-layer, sterile, non-adherent, antimicrobial barrier wound dressings. The Over-The-Counter Indications: Local management of superficial wounds, minor burns, abrasions and lacerations. Prescription Indications: Under the supervision of a healthcare professional Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlor® Island Wound Dressing and Silverlon® Wound Pad Dressing may help reduce the risk of wound infection and support the body's healing process. Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings may be used for the management of painful wounds, Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.

Silverlon Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost order): The Silverlon Wound Pad Dressing is comprised of Layers 1 - 4, they are not supplied with Layer 5 (adhesive tape layer). - . Layer 1 is a non-adherent wound contact layer that consists of a single layer of knitted continuous nylon fiber coated with metallic silver at the rate of 5.05 mg/cm (50.5 g/m²); the silver surface coating is approximately 0.8 - 1.0 µm thick and contains approximately 1% silver oxide). - . Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer described below; - Layer 3 is a laminate pad with an absorptive capacity of 65 oz/yd2 to absorb wound . exudate; - . Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below; and, - Layer 5 is a non-woven, medical grade polyester fabric coated on the skin-contacting . side with a self-curing acrylic, pressure-sensitive, medical grade adhesive covered with a silicone-coated (one side) paper liner. The Silverlon Wound Pad dressings do not have a tape layer. All materials are biocompatible per irritation, sensitization and cytotoxicity testing results. Layer 1 delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provide an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and the dressing intimately conforms to the wound surface.

Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and the Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing are intended to provide moist wound environment and are used for the management of chronic, acute, surgical, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic}, partial-thickness burns, flaps and grafts; when used in conjunction with an NPWT pump that is intended to be used for negative pressure wound therapy (NPWT), the NPWT system is indicated for patients who benefit from wound management therapy via the application of negative pressure wound of fluids and excess exudates, infectious material, and tissue debris which may promote wound healing. It provides a non-adherent, conformable, antimicrobial barrier and may help reduce infection when placed under reticulated foam, gauze, or other wound fillers. Silverlon® Fenestrated Wound Contact Dressings may be cut or overlapped to fit any wound size.

Silverlon® Fenestrated Wound Contact Dressings-Models Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing are sterile, porous, non-adherent, knitted with 99% elemental silver and 1% silver oxide. The dressings may promote wound healing via assisting the removal of fluids, including body fluids, wound exudates and infectious materials. The Silverlon® Fenestrated Wound Contact Dressing delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. The Silverlon® Fenestrated Wound Contact Dressings are used as the primary wound contact layer for NPWT dressing sets and is placed under reticulated foam, gauze, or other wound fillers. Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing are non-adherent, wound care dressings designed to be used in negative pressure wound therapy dressing sets up to seven (7) days. Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing is a non- adherent, wound care dressings designed to be used in negative pressure wound therapy dressing sets up to three (3) days.

Silverlon® Island Wound Dressings is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing. The Over-The-Counter Indications: Local management of superficial wounds, minor burns, abrasions and lacerations. Under the supervision of a healthcare professional Silverlon Island Wound Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, surgical wounds (donor and graft sites, incisions), and partial to fill thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). Silverlon® Island Wound Dressing is indicated for the management of infected wounds', as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Island Wound Dressing may help reduce the risk of wound infection and support the body's healing process. Silverlon® Island Wound Dressing may be used for the management of painful wounds' Silverlor® Island Wound Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may sooth the wound. 1Clarified/New Indication, not previously included in this format under K984208.

Silverlon® Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost to outermost order): · Layer 1 is a non-adherent wound contact layer that consists of a single layer of knitted continuous nylon fiber coated with metallic silver at the rate of 5.05 mg/cm (50.5 g/m²); the silver surface coating is approximately 0.8 - 1.0 um thick and contains approximately 1% silver oxide). - · Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer described below; - · Laver 3 is a laminate pad with an absorptive capacity of 65 oz/yd2 to absorb wound exudate; · Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below; and, · layer 5 is a non-woven, medical grade polyester fabric coated on the skin-contacting side with a self-curing acrylic, pressure-sensitive, medical grade adhesive covered with a silicone-coated (one side) paper liner. Laver 1 delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and the dressing intimately conforms to the wound surface.

Silverlon™ CA Advanced Antimicrobial Alginate Dressing is an effective barrier to microbial penetration for moderate to heavy exudating partial and fullthickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree burns. Silverlon™ CA Advanced Antimicrobial Dressing is indicated for external use only.

Silverlon™ CA Advanced Antimicrobial Alginate Dressing, is a sterile, non-woven pad composed of a calcium (and sodium) alginate and a silver nylon contact layer. The dressing is available in various sizes ( 2" x 2", 4.2", 4.25" x 4.25", 4" x 8", 8" x 12", and a %" x 12" rope) and packaged in Tyvek pouches. The release of silver ions provides an antimicrobial barrier, which protects the dressing from microbial colonization. The dressing absorbs exudates, maintains a moist wound environment and allows for intact removal.