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Components: |
Drain, transparent |
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Materials: |
Drain: medical polyvinyl chloride (PVC) |
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Specifications: |
Kink-resistant, smooth |
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Length: 50cm |
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Radiopaque broken line (sentinel line): broken at the first proximal eyelet (Sentinel eye). |
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Numerical graduations: every 2cm. |
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Eyelets: lateral atraumatic eyelets (holes). |
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Distal end or tip: open and atraumatic rounded end. |
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Proximal end or tip: bevelled for atraumatic tissue crossing. |
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CH 16: diameter 5.3cm; 4 lateral eyelets |
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CH 20: diameter 6.6cm; 5 lateral eyelets |
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CH 24: diameter 8.0cm; 6 lateral eyelets |
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CH 28: diameter 9.3cm; 6 lateral eyelets |
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CH 32: diameter 10.6cm; 6 lateral eyelets |
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CH 36: diameter 12.0cm; 6 lateral eyelets |
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Connector: towards drainage tube: conical with increasing diameter. |
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Unit presentation: |
1 catheter, sterile, single-use |
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Packaging: |
Unit presentation: Must be supplied with double packaging: one interior layer plus a sterilized peel pack.
Labelling: Name and/or trademark of the manufacturer, "sterile", lot number, expiry date by year and month, "for single use", CE mark and reference number of notifying body, product description, and instructions for use. Must be multilingual: English, French and Spanish, others when available. |
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Secondary packaging: |
Protected unit, one (1) box with 10-unit presentation, labelling is the same as primary packaging. |
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Additional 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: |
Quality complies with Medical Device Directive 93/42EEC, risk class IIa |