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813*00_en_GB_TECHNICAL_DATA_SHEET

813*00_en_GB_TECHNICAL_DATA_SHEET

813*00_en_GB_TECHNICAL_DATA_SHEET

Product catalog summary
Features & Benefits
  • Airy and extensible non-woven material.
  • Aesthetic and covering cap design.
  • Instructions for use include turning seams for aesthetics and adjusting height by turning the edge.
  • Recommended for use by nurses, surgeons, or patients in the operating room.
Technical Description
  • Product Name: MEDICOM Surgical Caps.
  • Type: Single use, non-sterile.
  • Material: 84% Viscose, 16% Ethylene copolymer-vinyl acetate.
  • Color Options: Blue and Green.
  • Dimensions: Circumference 56 cm (± 2 cm), Height 32 cm (± 2 cm).
  • Unit Weight: 7.2 g (± 10%).
  • Packaging: Dispenser box of 100 units.
  • Origin: France.
  • Medical Device Class I.
Mechanical and Microbiological Information
  • Bioburden evaluation meets EN ISO 11737: 2018+A1 2021 standards.
  • Additional microbiological controls include ASR, E.coli, and Staphylococcus.
  • Grammage: 40 g/m² (± 10%) as per ISO 9073-1.
  • Tensile Strength (ISO 9073-3): MD 55.4 N (± 10%), CD 8.6 N (± 10%).
  • Elongation (ISO 9073-3): MD 10.5% (± 10%), CD 71.1% (± 10%).
Logistical Information
  • Outer Case Size: 575 x 225 x 370 mm, Gross Weight: 4.6 kg, 35 cases per pallet.
  • Dispenser Box Size: 200 x 108 x 350 mm, contains 5 boxes of 100 pieces each.
  • Storage Conditions: Store in a cool environment, away from moisture and sun. Product life is 5 years.
Standards & Certification
  • Manufactured under ISO 13485 certified quality system.
  • Conforms to EN ISO 14971 standards.
  • Complies with Regulation (EU) 2017/745 for Medical Devices.
Precautions
  • Use only on clean, intact skin.
  • Re-use or prolonged use may cause infection or cross-contamination.
  • Dispose of according to national regulations.
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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

 Open the catalog to page 1
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...

 Open the catalog to page 2
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