Healthcare Materials - medical grade silicones

 

Nusil Technology's healthcare 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.

NuSil Technology offers a complete line of silicone materials for use in the health care industry. 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 are clones of discontinued originals manufactured by other companies. Masterfiles and test data compendia (including physical, chemical and biological testing) are made available on all NuSil Technology medical products to ease approval through the FDA on vendor changes, 510K's, IDE's and PMA's.

Using this expertise, NuSil Technology expanded this 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 well.

For over 15 years we've been advancing the standards for manufacturing silicone products and this experience allows us to offer a broad spectrum of standard and customer formulations with unparalleled lot-to-lot consistency. As an ISO-9001 certified company, all materials are manufactured and processed under strictly controlled conditions and are completely traceable.