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Custom Compounding

Custom Compounding

Custom Silicone Materials Overview

At Saint-Gobain, we develop formulations with the needs of medical device manufacturers in mind. Our silicone products are preferred by our medical device customers for their superior characteristics, consistency and performance. Saint-Gobain’s family of products includes Bio-Sil Platinum Cured Silicone. These high purity products are ideal for medical devices requiring flexibility, durability, long life and non-reactivity with bodily fluids and skin. Available Bio-Sil products include Bio-Sil 1450 Silicone Tubing and Bio-Sil Precision Pump Tubing.

Want to learn more about Silicone? Check out Basics 101: Silicone. 

Questions about the wonders of Bio-Sil®? Learn more here. 

 

About Saint-Gobain

Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in so many industrial applications.

 

Saint-Gobain Performance Plastics' group of businesses gather solutions to save energy, provide protection, improve comfort and sustain the environment for a variety of markets.

 

Saint-Gobain’s medical products are distributed exclusively to medical device manufacturers for use in the manufacture, assembly or distribution of their medical devices. Saint-Gobain cannot authorize the sale of its medical products directly to device user facilities (e.g. hospitals, surgery centers, nursing home, clinics, etc.), nor directly to end users (e.g. patients, patients’ caregiver, prescribing physician, nurse, pharmacist, etc.), including distributors serving device user facilities and end users directly. In accordance with every jurisdiction globally, Saint-Gobain’s customers are responsible for determining that any medical device they manufacture and market that incorporates a Saint-Gobain’s medical product, is compliant with each country-specific medical device regulations and has received proper country-specific clearance, certification or registration authorizing the sale of this medical device.
Saint-Gobain’s medical products offer covers:
-          Medical Components [21 CFR 820.3(c)], intended for processing or use in the manufacture or assembly of medical devices before the finished medical device is packaged/labeled; Medical Components are intended to be included as part of the finished, packaged, and labeled device [21CFR820.3(c)].
-          Finished Devices [21CFR820.3(l)] made on behalf of medical device manufacturers [21 CFR 807.20(a)(2)] under contract-manufacturing agreement. In accordance with the United States’ jurisdiction, Saint-Gobain complies with the FDA’s requirements for contract manufacturers of finished devices.

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