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Weck Cardiac Pacing Wires are intended for use in temporary cardiac pacing following cardiac surgery in adult and pediatric patients.

Weck cardiac pacing wires consist of a small curved stainless steel needle attached to fluoropolymer coated stainless steel braided wire which is attached on the opposite end to a Keith or Milner breakaway needle (see picture below). The wire is bare at the distal end to allow conduction of pacing signals to the heart. This is a standard temporary epicardial pacing wire design. There are three design variations included in this submission that are offered as a convenience to the user: 1. Color coding White and orange color coding of the insulation allows the user to differentiate between atrial and ventricular wires after chest closure. 2. Heart needle Three heart needle sizes are intended to allow for variations in physiology between patients. Another variation has no curved heart needle for surgeons who prefer to suture the wire to the epicardium rather than implanting it. 3. Retention feature A "wing" version wire is formed by peeling back the insulation in three places, 120° apart, for a distance of 1/2" near the curved heart needle. The "wing" is intended as a convenience feature to provide a suture-free method of securing the electrode to the heart.

Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Weck Closure System's Hem-O-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-O-Lok® causes hemostasis through vessel ligation. The clip is nonabsorbable and is manufactured from polyacetal. The clips are housed in a cartridge and packaged in a rigid plastic blister with Tyvek coated lidding which is sold sterile. The method of sterilization will be EtO with a SAL of 10°. The blister packs are fitted into an overpack carton which serves as the sales unit.

Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should match clip size to the size of the vessel or tissue structure to be ligated.

Weck Closure System's Hem-O-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-O-Lok® causes hemostasis through vessel ligation. The clip is nonabsorbable and is manufactured from polyacctal. The clips are housed in a cartridge and packaged in a rigid plastic blister with Tyvek coated lidding which is sold sterile. The method of sterilization will be EtO with a SAL of 10°. The blister packs are fitted into an overpack carton which serves as the sales unit.

Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should match clip size to the size of the vessel or tissue structure to be ligated.

Weck Closure System's Hem-O-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-O-Lok® causes hemostasis through vessel ligation. The clip is nonabsorbable and is manufactured from polyacetal. The clips are housed in a cartridge and packaged in a rigid plastic blister with Tyvek coated lidding which is sold sterile. The method of sterilization will be EtO with a SAL of 10 . The blister packs are fitted into an overpack carton which serves as the sales unit.

Horizon ligating clips are indicated for procedures involving vessels or anatomic structures where I iorizon ligating this are the best clip size, type and material based upon experience, judgement and needs.

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