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The product is medical silicone strip:width: 15 mm + 0, 6 mm ; thickness: 0, 6 mm +/- 0, 1 mm ; The colour pink. Material liquid silicone rubber 40 shore , post cured.The product is medical silicone is for one use and have to be produce in cleaning room and to be delivery in a double PE packaging by rolls of about 50 meter each.Final packaging and gamma radiation will be process by us.The silicone stays inside the human body less then 21 day.There must be a FDA approval for medical use for the material and the producer! The required data For QA & RA dept.:1. Biological and mechanical tests results.2. Material spec. - chemical composition and mechanical properties.3. Manufacturing process flow chart.4. COA with each shipment.5. Packaging specification (storage conditions, packaging sizes, graphical symbols.6. Certifications ().7 Results of stability of material after gamma radiation medical silicone medical silicone strip- FDA approved
