In 2004 an idea was conceived by Gayson SDI and our partner, NuSil Technology, to introduce a silicone color masterbatch line specifically for the healthcare industry. The combined experience of both NuSil and Gayson SDI ensure proper regulatory documentation and consistent product quality.

Standard pallets of eight colors for both high consistency silicone polymers (MED-4102) and liquid silicone polymers (MED-4900) are now available for restricted use short-term implantable (restricted use, less than 29 days) applications or external healthcare applications. The MED-4102 and MED-4900 product lines are supported by USP Class VI biological testing in accordance with ISO 10993 and GLP including;

                                             - Systemic Toxicity Study w/Extracts
                                             - Intracutaneous Study w/Extracts
                                             - 7 Day Muscle Implantation
                                             - Hemolysis

Standard pallets of eight colors for both high consistency silicone polymers (MED-4502) and liquid silicone polymers (MED-4800) are now available for use in unrestricted healthcare applications. The MED-4502 and MED-4800 product lines are supported by USP Class VI biological testing including a 90 Day Implantation Test, also in accordance with ISO 10993 and GLP.

Master Access Files for all four product lines (MED-4102, MED-4900, MED-4502, and MED-4800) will be filed with the U.S. Food and Drug Administration. Customers interested in authorization to reference the Master Access File must contact NuSil Technology.



Click here to return to the Gayson Homepage