Silicones: Health Care Materials

NuSil Technology offers a complete line of silicone materials for use in the health care industry. These materials are classified as unrestricted or restricted. Unrestricted products may be considered as candidate materials for any application, including long term implantation of greater than 29 days. Usage of Nusil’s restricted products, however, is limited to external use or for short term implant applications of 29 days or less. 
In 1993 NuSil Technology was uniquely positioned to respond to the availability crisis of silicone materials for use in long term implant applications in the medical device market. Well established in the medical silicone market and having firsthand knowledge of the products that were being discontinued, NuSil Technology responded to this situation by providing over 25 replacement products that were clones of discontinued originals manufactured by other companies.
Using this expertise, NuSil expanded their line of high performance silicones to offer competitively priced materials for use in external applications or for medical devices implanted up to 29 days in the body. Many of these silicone biomaterials are used in applications requiring USP Class VI certifications. Full testing and traceability are offered on these products.
As an ISO-9001 certified company, all materials are manufactured and processed under strictly controlled conditions and are completely traceable. Master files and test data compendia (including physical, chemical and biological testing) are available on all NuSil Technology medical products to ease approval through the FDA on vendor changes, 510K's, IDE's and PMA's.