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Advanced Medical Solutions Group plc Spyrogel Hydrogel Wound and Burn Dressing SA is intended for OTC use on: Superficial wounds such as, minor cuts, lacerations and minor burns and scalds

Advanced Medical Solutions Group plc Spyrogel® Hydrogel Wound and Rurn Dressing SA are supplied individually packaged in medical graum fuil pouches suitable for gamma irradiation. They are supplied to the market place as sterile dreasings. The intelligent film is as comercially distrubuted in the USA under 510(k) (K981753) June 30, 1998. The dressings are sterilized by gamma Irradiation. Isotron Laboratories provided Dose Mapping per ISO 11137, validation was undertaken in accordance with ISO 11137 Mothod 1. The verification dose required for a Sterllity Assurance Level (SAL) of 10-6 is 23.4 kGy. Starilization velidation data is on file at Isotron Laboratories. Biooompatability tosting has boon performed in accordance with ISO10983-1 Biological Evaluation of Medical Devices -- Part 1 Guidance on Selection of Tests First Edition. Data and Safety evaluation is as that submitted with aiready sporoved 510(k)'s K881753 and K982804. No components or raw materials have changed therefore no resubmission of loxicity data its required.

The Advanced Medical Solutions Silicone Scar Management Sheet intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds. Advanced Modical Solutions Silicone Gel Scar Management Sheet is intended for OTC use for the management of: Old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Advanced Medical Solutions Silicone Scar Management Gel sheet is a soft, self-adhesive, semi-occlusive sheet made from medical grade silicone with a polyurethane film backing paper and a non siliconised polyester release paper. The primary function of the dressing is to aid in the management of both existing and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds. The Advanced Medical Solutions Silicone Scar Management Sheet comes in two sizes 3in. x 4in. and 1in. x 4in. the sheet maybe cut or trimmed to the desired shape or size prior to placement on the scar, also two or more sheets may be placed together to cover a scar area that is greater than the area of a single sheet. The Advanced Medical Solutions Silicone Scar Management Sheet is self adhesive but can also be secured by a lightly conforming bandage or tape if so desired. The gel sheets are supplied either sterile or non-sterile in foil laminated sterilizable pouches.