{"product_id":"compresse-di-garza-cotone-piegata-secusorb-cm-10-x-20-a-16-strati-sterile-conf-5-pz","title":"SECUSORB folded cotton gauze swabs 10 x 20 cm, 16-ply - Sterile (Pack of 5 pcs.)","description":"\u003cp class=\"MsoNormal\"\u003e\u003cb\u003eSterile, folded pure cotton hydrophilic gauze swabs, type 20 F.U., without radiopaque thread, in blisters \u003c\/b\u003e\u003cbr\u003e Dimensions: 10 x 20 cm, 16 layers \u003cbr\u003e Packaging: blister pack of 5 pcs.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eIntended use:\u003c\/b\u003e\u003cbr\u003e Class IIa medical device\u003cbr\u003e Compliant with Directives 93\/42 EEC and 2007\/47 EC and Legislative Decrees 46\/1997 and 37\/2010 as amended.\u003cbr\u003e Invasive surgical device for temporary or short-term use.\u003cbr\u003e May be used to control the microenvironment of a wound.\u003cbr\u003e May be used in contact with injured skin as a mechanical barrier, for compression, and for the absorption of exudates.\u003cbr\u003e \u003cb\u003eRaw materials used:\u003c\/b\u003e\u003cbr\u003e Hydrophilic cotton gauze for dressings - characteristics and composition:\u003cbr\u003e 100% cotton, compliant with Legislative Decree 194 of 22.05.1999 as amended – compliant with UNI EN 14079:2004 \u003cbr\u003e Count 12\/8 - type 20 corresponding to current F.U. (Italian Official Pharmacopoeia), latest edition and subsequent updates.\u003cbr\u003e Pure white, non-reflective color - weight 27 g\/sqm\u003cbr\u003e \u003cbr\u003e \u003cb\u003eProduct characteristics:\u003c\/b\u003e\u003cbr\u003e Swabs folded in multiple overlapping layers, with cut edges turned inward and free of fraying, and reinforced by an additional inward fold (American fold) – this type of folding allows for use with maximum \"long\" opening, ensuring maximum safety during use.\u003cbr\u003e \u003cb\u003e\u003cbr\u003e Packaging (PVC-free, to reduce the possibility of pollution during disposal, according to EEC standards):\u003c\/b\u003e\u003cbr\u003e The swabs are packed in blisters – sterilization pouches, visible from the outside.\u003cbr\u003e Packaging in peel-open sterilization pouch with opening guide (see explanatory illustration for opening method), compliant with reference standards - UNI EN ISO 11607-1, pouches closed and sealed with heat sealing,\u003cbr\u003e consisting of:\u003cbr\u003e - Medical-grade paper (composition: see technical specification), minimum weight 60 g\/sqm, with low delamination, low porosity, resistant to mechanical stress, and with printed chemical indicators of sterilization, not in contact with the contained material – thickness ≥ 76 μ – air permeability ≥ 235 ML\/min. – seal width ≥ 7 mm.;\u003cbr\u003e - Colored transparent polypropylene\/polyester plastic film (see technical specification).\u003cbr\u003e Compliant with point 8 “Infection and microbial contamination” of Annex 1 of Legislative Decree 46\/97 as amended.\u003cbr\u003e Packed in a polyethylene bag, resistant to accidental breakage, dust-proof, and protective against humidity and any pollutants and\/or contamination of the sterile packages deriving also from contact with the outer cardboard, and outer cardboard box compliant with G.I.F.C.O. standards – on Euro-Pallets.\u003cbr\u003e \u003cb\u003eSterilization:\u003c\/b\u003e\u003cbr\u003e Sterile packaging, sterilized with ethylene oxide (EtO), with validated sterilization cycles for an initial bioburden not exceeding 100 CFU\/g., in compliance with UNI EN ISO 11135 - UNI EN 556 standards (it is declared that the quantity of residual gas is less than “2 ppm”, in compliance with the provisions of the Ministry of Health with Circular number 56 of 22\/06\/83 and the current Official Pharmacopoeia);\u003cbr\u003e Sterility is guaranteed for five years, provided the packaging is intact and correctly stored.\u003cbr\u003e \u003cb\u003eLabeling:\u003c\/b\u003e\u003cbr\u003e The packages and packaging are labeled in accordance with European Directive 93\/42\/EEC, transposed by Legislative Decree 46 of 24\/02\/97, and in compliance with the latest edition of the F.U. and UNI CEI EN ISO 15223 as amended. The packages and packaging are available with a label applied containing the barcode identifying the product contained therein.\u003cbr\u003e \u003cb\u003eStability\/Validity of the device and storage conditions:\u003c\/b\u003e\u003cbr\u003e Devices with stability and validity guaranteed for at least 5 years, provided the packaging is intact and correctly stored - Store in a cool, dry place, at room temperature, away from heat sources, and protected from direct sunlight – recommended temperature: between +10°C and +25°C.\u003cbr\u003e  \u003c\/p\u003e","brand":"STS Medical Group","offers":[{"title":"Default Title","offer_id":49867806572880,"sku":"MM10397","price":1.95,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0866\/3996\/8592\/files\/garza10x20.jpg?v=1741064913","url":"https:\/\/www.cfs.it\/en\/products\/compresse-di-garza-cotone-piegata-secusorb-cm-10-x-20-a-16-strati-sterile-conf-5-pz","provider":"CFS Prodotti Medicali s.r.l.","version":"1.0","type":"link"}