FEATURES:

• SIZE - 15cm x 7.5cm x 1.5cm (6.0" x 3.0" x 0.6") block.
• SELECTION - Available in very soft, soft, medium and firm durometers.
• COLORS - Available in Non-pigmented (clear) and Pigmented (White or Flesh).
• SILICONE - High degree of biocompatibility.

BENEFITS & ADVANTAGES:

• Easy to cut to required size and shape using knife or scissors.
• Allows the physician to create custom implant configurations.
• Easy explantation with minimal trauma.
• Storage of unused portion in resealable poly bag.

APPLICATIONS: useful in the fabrication of

• Custom surgical implant for trauma injuries.
• Surgical implant to augment damaged bone or cartilage.
• Chin prostheses.
• Malar prostheses.

PRODUCT INFORMATION

Medical Implant Grade Silicone Block is a flexible silicone elastomer material designed for implantation to augment bone and cartilaginous tissue loss. It is supplied non-sterile.

Blocks are available in four degrees of firmness. They come in non-pigmented (clear) and pigmented (white or flesh) colors.

• Very Soft block - made from a very soft durometer (10 Shore A) silicone elastomer available in clear color.
• Soft block - made from a soft durometer (20 Shore A) silicone elastomer available in clear color.
• Medium block - made from a medium durometer (30 Shore A) silicone elastomer available in clear color.
• Firm block - made from a firm durometer (50 Shore A) silicone elastomer in clear color.
• Pigmented block - contains barium sulfate. USP grade. Available in White and Flesh colors.

The advantages of BioPlexus Medical Grade Silicone Block include:

• Easy to cut to size and shape
• Allows physician to create custom implant configurations
• Will not attach to underlying or surrounding tissue
• Easy explantation with minimal trauma
• Storage of unused portion in resealable poly bag
• May be repeatedly autoclaved

APPLICATIONS

Silicone Block has been utilized to augment and reconstruct bone and cartilaginous tissue loss. The purchaser should thoroughly test products made in part or otherwise incorporating BioPlexus Implant Medical Grade Silicone Block to determine the acceptability of the products in a specific application.

INSTRUCTIONS FOR USE

Remove the silicone block from its package. Care must be taken to prevent possible surface contamination by materials such as talc, dust and skin oils which might adversely affect the suitability of implant. Scrub the silicone block thoroughly with a clean, soft sponge or soft bristled brush in a hot water and soap solution to remove skin contaminants. Use a non oily cleaner or mild soap. Do not use synthetic detergents or oil based soaps, as these soaps may be absorbed and may subsequently leach out to cause tissue reaction. Rinse copiously in hot water and follow with a thorough rinse in distilled water.

STERILIZATION

Steam

Wrap in lint-free material or place in a clean, open tray. Autoclave by the following method:

• Standard gravity sterilizer - 30 minutes at 121 degree C (250 degree F) and 15 psi (1 kg/cm)

Ethylene Oxide

Sterilization by ethylene oxide (ETO) is not recommended unless sufficient data is available regarding the time required for complete out gassing of residual ethylene oxide and other ETO by-products from the specific system employed.