8886442013

Novafil™ monofilament synthetic polybutester suture

Indications, Safety, and WarningsIndicationsNovafil™ polybutester sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmology.Warnings

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

This device is provided sterile and is intended for use in a single procedure only. Discard after use. Do not ResterIize. 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.

Discard open, unused sutures.

Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing Novafil™ sutures for wound closure as the risk of wound dehiscence may vary with the site of application and the suture material used.

Due to elasticity of the suture, extreme care and/or change in technique must be utilized when tensioning continuous or parachute sutures during vascular procedures or anastomotic bleeding may result.

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

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 non-absorbable 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.

The device contains nickel that may cause allergic reaction.

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