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Materials: |
Bleached, purified textile, plain weave. |
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Absorbent gauze, 100% cotton. |
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Woven. |
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Specifications: |
Type of gauze: 17 threads/cm² (23g/m²). |
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Number of plies: 8-12. |
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Thread count in cm² and square inch: |
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- Warp: 9 threads/cm²; 26/24 thread per square inch. |
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- Weft: 8 threads/cm²; 18 to 20 per square inch. |
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Nominal Length: 10 to 20cm. |
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Nominal Width: 10cm (alternatives: 5 x 5cm). |
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Features: |
Surgical folding: no loose threads apparent after folding or when the first outside layer is opened. |
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Not detectable by X-ray. |
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Unit presentation: |
2 sterile compresses, sterile peel pack, single-use |
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Packaging and labelling |
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Primary packaging: |
Should indicate: Manufacturer’s address and name and/or trademark, product description including size, Nr of plies, reference number for the type of gauze, "sterile", lot number, expiry date by year and month, "for single use", and CE mark plus reference number of notifying body. Must be multilingual: English, French and Spanish, others when available. |
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Secondary packaging: |
Protected unit, one (1) box of 40 to 50 sachets containing 2 compresses. Labelling is the same as primary packaging. |
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Additional required information: Number of units per secondary packaging, information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.). |
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Outer packaging: |
Packaging unit: Strong carton. |
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Other requirements: |
Quality must comply with Medical Device Directive 93/42 EEC or equivalent. |
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Meet pharmacopoeia specifications for medical use of bleached cotton. |
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Individual packaging should be avoided. |