What is the FDA approved material that the device is made from?
The RIPSNORE device is made from a material known as Dynaflex. Dynaflex G2706 thermoplastic elastomer (TPE) compound from GLS Corporation (made with Kraton polymer) has been approved to be used in applications that require United States Pharmacopoeia (USP) XIX class VI certification. This G2706 grade is also compliant to FDA CFR 177.1210 regulations for applications requiring FDA compliance.
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