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N-2546

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Monosof™ monofilament nylon sutures are inert, nonabsorbable, sterile surgical sutures used in general soft tissue approximation or ligation.

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Indications, Safety, and WarningsIndicationsMonosof ™ and Dermalon™ monofilament and Surgilon™ braided nylon sutures, are indicated for use in general soft tissue approximation and/or ligation.ContraindictionsDue to the gradual loss of tensile strength which may occur over prolonged periods in vivo, nylon sutures should not be used where permanent retention of tensile strength is required.Warnings

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

This device is provided sterile for single-use only. Sterile unless sterile barrier system(s) has been opened or damaged. Visually inspect the packaging and the sterile barrier system before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment or life-threatening injury. Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing Monosof ™, Dermalon™, or Surgilon™ sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.

The subject device should not be used in patients who are allergic to device materials.

These sutures are not intended to be used in the cardiovascular system.

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