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813*00_en_GB_TECHNICAL_DATA_SHEET
1 /2Pages

813*00_en_GB_TECHNICAL_DATA_SHEET

813*00_en_GB_TECHNICAL_DATA_SHEET
1 /2Pages

Catalog excerpts

813*00_en_GB_TECHNICAL_DATA_SHEET-1

Technical Data Sheet Made In France 813600 Surgical Caps 813700 Medical Device Class I FEATURES & BENEFITS • Airy and extensible non-woven • Very aesthetic and very covering cap 1. To be more aesthetic, turn the seams 2. Adjust the height by turning the edge Recommendation : • Can be used by nurses, surgeons or patients in the operating room TECHNICAL DESCRIPTION Product name: Product type: Material : Confection : Color : Dimensions : Unit weight : Packaging: Origin : MEDICOM Surgical caps - Surgical caps Single use, non sterile 84% Viscose + 16% Ethylene copolymer- vinyl acetate Sewn Blue / Green Dispenser box of 100 units France Manufacturing Microbiological Information (by icare Laboratory) Bioburden evaluation meets the requirements of EN ISO 11737: 2018+A1 2021 Additional microbiological controls: ASR, E.coli, Staphylococcus. Do not use if package is damaged Rev02 Page 1/2

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813*00_en_GB_TECHNICAL_DATA_SHEET-2

STANDARDS & CERTIFICATION Manufactured under ISO 13485 certified quality system. In conformity with the relevant harmonized standard EN ISO 14971. Complies with the requirements of Regulation (EU) 2017/745 relating to Medical Devices. Normal conditions of conservation & storage: not to be exposed to moisture and sun, store in a cool environment or at room temperature. Product life: 5 years. The device should only be used on clean, intact skin. Their re-use or prolonged use can produce infection or cross-contamination. After use, comply with the national regulations in force for the disposal of...

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