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Materials: |
100% hydrophilic cotton, medical grade. |
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Bleached purified, woven, plain weave. |
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Specifications: |
Type of gauze: 17 threads/cm² or 44 threads by square inch. |
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Thread count in cm² and square inch: |
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- Warp: 9 threads/cm², 26/24 threads/square inch |
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- Weft: 8 threads/cm², 18 or 20 threads/square inch |
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Weight: minimum 23g/m² |
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With selvedge to prevent the gauze from fraying. |
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Features: |
Nr. of folds (thickness): 8 to 12 |
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Surgical folding: no loose threads appear after folding, and when first outside fold is opened. |
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Not detectable by X-ray. |
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Not sterile, steam sterilization recommended. |
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Unit presentation: |
1 hygienically clean compress for medical use. |
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Primary packaging: |
100 compresses in a protective paper bag, packed in a suitable carton. |
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Manufacturer’s name and/or trademark and address, product description including size, number of plies, type of gauze and reference number, lot number, "for single use", and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available. |
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Outer packaging: |
Packaging unit: number in primary units. |
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Labelling same as that of primary packaging. |
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Information for product-specific storage conditions (temperature, pressure, light, humidity, etc.). |
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Strong carton. |
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Other requirements: |
Quality must comply with Medical Device Directive 93/42 EEC and pharmacopeia specifications for bleached cotton gauze. |