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SureSkin Silver bandages are indicated for first aid to help minor cuts, scrapes, abrasions, lacerations, blisters and scalds.

SureSkin Silver bandages are sterile, single-use dressings that consist of silver -containing hydrocolloid adhesive bonded to an outer polyurethane film cover for an antimicrobial effect. The hydrocolloid adhesive is designed to interact with moisture from the skin and wound surface where it forms a gel and creates a moist wound environment that is known to speed the healing process faster than commonly used bandages Once the bandage begins to interact with moisture the silver in the adhesive is activated and helps to kill bacteria which are in direct contact with the dressing.

The SureSkin III with Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. The SureSkin III with Silver BORDER wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers. The SureSkin™ III with Silver THIN wound dressings are indicated for the management of dry or lightly exudating wounds, such as dermal ulcers, post-operative wounds, superficial wounds and abrasions. The SureSkin™ III with Silver wound dressings are also indicated for use on second degree burns and donor sites.

The SureSkin III with Silver Wound Dressings are identical to the SureSkin II products with the exception that the formulation has been slightly modified to include silver. The SureSkin III formulation includes the same well-known materials that are used in other hydrocolloid wound dressings. Polyurethane film (Border/Thin) backings provide an occlusive covering of the wound. The polyurethane backing (film) is impermeable to water and bacteria. The dressing maintains a constant thickness of hydrocolloid material to the edge of the dressing. The thickness of the hydrocolloid material is decreased at the edges (beveled edges) of the Border Dressing to improve adherence and reduce the risk of the dressing rolling up. The border itself is a continuation of the hydrocolloid adhesive material. The dressings can be left in place up to seven days if exudate is minimal.

The SureSkin II STANDARD and SureSkin II BORDER hydrocolloid wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers. The SureSkin™ II THIN hydrocolloid wound dressing is indicated for the management of dry or lightly exudating wounds, such as dermal ulcers, post-operative wounds, superficial wounds and abrasions. The SureSkin™ II dressings are also indicated for use on second degree burns and donor sites.

The SureSkin II wound dressings are identical to the SureSkin Plus products with the exception that the formulation has been slightly modified. The SureSkin II hydrocolloid wound dressing formulation includes the same well known materials w that are used in other hydrocolloid wound dressings. The adhesive hydrocolloid surface of these wound dressings is in contact with the wound bed. Polyurethane foam (Standard) and polyurethane film (Border/Thin) backings provide an occlusive covering of the wound. The polyurethane backing (foam or film) is impermeable to water and bacteria. The dressing maintains a constant thickness of hydrocolloid material to the edge of the dressing (Standard and Thin). The thickness of the hydrocolloid material is decreased at the edges (beveled edges) of the Border Dressing to improve adherence and reduce the risk of the dressing rolling up. The border itself is a continuation of the hydrocolloid adhesive material. The dressings can be left in place up to seven days if exudate is minimal.

The SureSkin™ Plus STANDARD and SureSkin™ Plus BORDER hydrocolloid wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers. The SureSkin™ Plus THIN hydrocolloid wound dressing is indicated for the management of dry to lightly exudating wounds, such as pressure sores and leg ulcers. The SureSkin™ Plus dressings are also indicated for use on superficial wounds and abrasions. second degree burns, and donor sites.

The new SureSkin™ Plus Standard, SureSkin™ Plus Border, and SureSkin™ Plus Thin hydrocolloid wound dressings are identical to the predicate SureSkin™ products except for a slight change in the hydrocolloid materials. The materials are the same except that mineral oil has been added and gelatin has been omitted from the hydrocolloid. The SureSkin® Plus Hydrocolloid Wound Dressings manufactured by Euromed, Inc. are wound dressings composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane backing. The dressing is identical in design, function and intended use to the commercially available predicate SureSkin™ wound dressings. The only difference is the slight change in formulation of the materials.

Neuromed, Inc.'s One-Step Connect™ Leads are intended to be used with Neuromed trial extensions and/or receivers, transmitters, and antennae to electrically stimulate spinal cord fiber tracts for treatment of chronic pain of the extremities and/or trunk. The proposed device modification does not affect the original intended use of the legally marketed device.

Neuromed, Inc.'s One-Step Connect™ Leads are implantable devices consisting of spaced electrodes connected by wires within a cover sheath. These percutaneous leads are introduced into the epidural space superior to the spinal segment responsible for pain impulse transmission, and connected to a radiofrequency (RF) receiver or pulse generator.