PACKAGING: Sterify Gel is supplied sterile, in copolyester (CPE) syringe with polycarbonate (PC) cap, in aluminum/coupled (ALU/PE) pouch, single. Instructions and card(s) for the patient. The product label is placed on the outer box (final packaging case), and the outside of each sterile package contained in the box is affixed with the sterile packaging label.
STERILIZATION: Sterify Gel is sterilized by gamma irradiation at 25 kGy.
STORAGE: For the storage of the Sterify Gel device, a protected environment that preserves it from direct exposure to light and heat sources, clean, dry, and allows the packages to be stored in a way that prevents the degradation and contamination of the product must be ensured. To maintain sterility, it is important to store it in its original packaging at room temperature (15°C<T<25°C) and prevent damage; if stored properly, the integrity of the packaging and sterility of the device is guaranteed for 3 years from the date of manufacture. DISPOSAL: Any unused product residue should not be stored and used in other surgeries or for other patients, but should be disposed of as contaminated hospital waste according to the regulations in place at the dental office. Consumable components associated with device application, such as the syringe and needle, should be disposed of. The materials constituting the package do not require special disposal conditions. INFORMATION PROVIDED TO PATIENTS The device is accompanied in each package by a patient information sheet, which contains clear and easily understood basic information about the implanted device, which also allows for its identification. This information sheet is accompanied by a card that contains the main information about the device and the patient identification data. Health care institutions must make available to the patient to whom the device has been implanted the information sheet and the implant card, to which the label containing the device traceability data is to be attached and to be filled out indicating the patient's name, date and place of surgery, before being handed over to the patient. SUMMARY RELATED TO SAFETY AND CLINICAL PERFORMANCE Sterify has prepared, in accordance with Article 32 of MDR 2017/745, a summary regarding the safety and clinical performance (SSCP) of the Sterify Gel device, which can be found on the European Eudamed database at https://ec.europa.eu/tools/eudamed, where it is linked to the product's Basic UDI-DI (80593888501W4).
PRODUCT CODES: REF. STY-GEL0301, Sterify Gel - 0.3 ml, 1 syringe. REF. STY-GEL0303, Sterify Gel - 0.3 ml, 3 syringes. REF. STY-GEL0501, Sterify Gel - 0.5 ml, 1 syringe. REF. STY-GEL0503, Sterify Gel - 0.5 ml, 3 syringes. REF. STY-GEL1001, Sterify Gel - 1 ml, 1 syringe. REF. STY-GEL1003, Sterify Gel - 1 ml, 3 syringes. REF. STY-GEL0301HM, Sterify Gel HM - 0.3 ml, 1 syringe. REF. STY-GEL0303HM, Sterify Gel HM - 0.3 ml, 3 syringes. REF. STY-GEL0501HM, Sterify Gel HM - 0.5 ml, 1 syringe. REF. STY-GEL0503HM, Sterify Gel HM - 0.5 ml, 3 syringes. REF. STY-GEL1001HM, Sterify Gel HM - 1 ml, 1 syringe. REF. STY-GEL1003HM, Sterify Gel HM - 1 ml, 3 syringes.
Sterify S.r.l. Via Nizza, 262/1 – 10126 Torino (TO), Italy +39 011 2173 3224 – info@sterify.it – www.sterify.it
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