Cook Endoscopy

Product Order Number: MBL-10, Lot No. W2758471, W2758472, W2758474, W2760365, 22760366, 22760380, W2763652, W2764330, W2764331, W2764332, W2772073, W2772074 and W2772075; MBL-10-F, Lot No. W2763624, W2763626, W2763634, W2767450, W2768607, W2768615, W2768616, W2768617, W2770052, W2773557 and W2773558; MBL-10-I, Lot No. W2767442; MBL-10-XS, Lot No. W2787044, W2795540 and W2796313.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, WA, WI, WV, and WY; and the countries of Algeria, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Georgia, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Mexico, Malaysia, Morocco, Netherlands, New Zealand, Peru, Poland, Portugal, South Africa, Slovakia, Spain, Switzerland, United Arab Emirates, UK and Venezuela.

Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 || This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

Product Order Number: MBL-10, Lot No. W2758471, W2758472, W2758474, W2760365, 2760366, 2760380, W2763652, W2764330, W2764331, W2764332, W2772073, W2772074 and W2772075; MBL-10-F, Lot No. W2763624, W2763626, W2763634, W2767450, W2768607, W2768615, W2768616, W2768617, W2770052, W2773557 and W2773558; MBL-10-I, Lot No. W2767442; MBL-10-XS, Lot No. W2787044, W2795540 and W2796313.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, WA, WI, WV, and WY; and the countries of Algeria, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Georgia, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Mexico, Malaysia, Morocco, Netherlands, New Zealand, Peru, Poland, Portugal, South Africa, Slovakia, Spain, Switzerland, United Arab Emirates, UK and Venezuela.

Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 || This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

Lot number W2501093

Gastroenterology-Urology Devices

2

No

Ireland

FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Technology Park, Limerick, Ireland. The Fusion Omni-Tome is supplied sterile and is a single use device. This device is used in cannulation of the ductal system and for sphincterotomy.

Lot number W2243511, Expiration date 7/12/2009

2

No

Worldwide.

Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

DPOC-20, Lot number: W2834631

Gastroenterology-Urology Devices

2

Yes

Worldwide distribution: USA including states of: AL, CA, FL, IL, IN, LA, MA, NC, NY, OH, PA, SC, TN, TX, WA, and WI; and countries of: Belgium, Canada, Germany, Hong Kong, and the Netherlands..

DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical, Winston-Salem, NC 27105 || This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.