S-2782K

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<h2>Indications, Safety, and Warnings</h2> <h3>Indications</h3> <p>Sofsilk™ sutures are indicated for use in soft tissue approximation and/or ligation.</p> <h3>Contraindictions </h3> <p>The use of this suture is contraindicated in patients with known sensitivities or allergies to silk.</p> <p>Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, Sofsilk™ sutures should not be used where permanent retention of tensile strength is required.</p> <h3>Warnings </h3> <ul> <li>As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation. </li> <li>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. </li> <li>Acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds. </li> <li>During employment of the device, care should be taken to avoid damage to the surgical needles from handling. Grasp the needle in an area one-third to one half of the distance from the attachment end to the needle point. Grasping near the point could result in damage to the functional integrity or fracture the needle. Grasping at the attachment area could cause breakage of the needle barrel or the nonabsorbable suture in the attachment area. Reshaping needles may result in decreased resistance to bending and breaking. To avoid inadvertent needle stick injury, which may result in transmission of blood-borne pathogens, the user should exercise caution during handling of surgical needles and consider use of Protect Point™ modified taper needles where appropriate. </li> <li>The device contains nickel that may cause allergic reaction.</li> </ul>

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