Cook Incorporated

One-Step Suprapubic Introducer Cook Sterilization Case UPJ Occlusion Balloon Catheter Set Soules Intrauterine Insemination Catheter San Antonio Stopcock Brush Biopsy Set Odyssey Holmium Laser System Novy Corneal Cannulation Set Greene Renal Transplant Stent Set Wire Guide With Hydrophilic Coating Laser Ureteral Catheter Side Arm Adapter Foley Adapter/Connector Luer Lock Cap Disposable Stopcock Flexor Vision Endoscopic Introducer/Extractor Pediatric Flexor Ureteral Access Sheath Percutaneous Neonatal Pigtail Nephrostomy Set Pediatric Nephrostomy Stent Set Salle Intraoperative Pyeloplasty Stent Set With 6cm Stylet Salle Intraoperative Pyeloplasty Stent Set With 3cm Stylet Sof-Flex® Double Pigtail Ureteral Stent Set Sof-Flex® Multi-Length Ureteral Stent Set Surgical Urine Drain Pouch Set Flexi-Tip® Dual Lumen Ureteral Access Catheter With AQ® Hydrophilic Coating Dual Lumen Ureteral Access Catheter Dual Lumen Ureteral Catheter With AQ® Hydrophilic Coating Flexi-Tip® Dual Lumen Ureteral Access Catheter MagniCore Precision Chiba iMRI Needle MagniCore Precision Coaxial iMRI Needle Amplatz Renal Dilator Set Koyle Diaper Stent Zaontz Urerthral Stent Firlit-Kluge Urethral Stent Silicone Rectal Balloon Cook 810 Set Desilets-Hoffman Introducer Set Desilets-Hoffman Introducer Set With Radiopaque Band Williams Cystoscopic Injection Needle Elongated Cup Biopsy Forceps Cup Biopsy Forcepts Selikowtiz Ureteroscopic Knife Hatter Flexible Cystoscopy Aspiration Tube Connecting Tube OBrien Suprapubic Peel-Away® Access Set Cook® SP Tube Introducer Set Rutner Universal Wedge Catheter Cone Tip Ureteral Catheter with Open-End Cone Tip Ureteral Catheter CHIBA DECOMPRESSION SET Universal Check Flo Adapter Female Luer Lock Cap Dual Male Luer Lock Adapter Dual Check Valve Anesthetic Gel Adapter Endoscopic Tuohy Borst Adapter Ultraxx Nephrostomy Balloon Set Ultraxx Nephrostomy Balloon Set with TFE Sheath FUSION LITHOTRIPSY EXTRACTION BASKET MEMORY SOFT WIRE BASKET MEMORY HARD WIRE BASKET THE WEB EXTRACTION BASKET Soft-Pass EchoTip Embryo Transfer Catheter Pivet Guide Embryo Transfer Catheter Set Soft-Pass EchoTip Embryo Transfer Catheter Set Soft-Pass Embryo Transfer Catheter Set Urethral Dilator Set Onik-Cohen Percutaneous Access Set Selective Salpingography Catheter Intrauterine Access Balloon Catheter Malecot Nephrostomy Catheter/Stent Set Frova Intubating Introducer with Rapi-Fit Adapters Frova Intubating Introducer with Stiffening Cannula Deflectable Brush Biopsy Set VersaTube Tapered Tracheostomy Tube with Disposable Inner Ca Bakri Essential Postpartum Balloon Disposable Cervical Dilators Cook Silicone Balloon HSG Catheter Cook Silicone Balloon HSG Catheter With Closed End And Sideport Black Silicone Filiform Double Pigtail Ureteral Stent Set Non-Toxic Syringe Vacuum Syringe Taylor Gel Adapter Guardia Access Nano Embryo Transfer Catheter Amplatz Renal Introducer Amplatz Radiopaque TFE Sheath Catheter for Use with Amplatz Renal Dilator Set Clear Amplatz Sheath with Radiopaque Stripe Amplatz Dilator Laparoscopic Myoma Screw Hysteroscopic Myoma Screw Modified Novy Cornual Cannulation Set Flexor Ureteral Access Sheath with AQ Hydrophilic Coating Flexor Parallel Rapid Release Ureteral Access Sheath with AQ Hydrophilic Coating Ball Tip Fulgurating Electrode Balloon Ureteral Dilator Set Balloon Ureteral Dilator Cook Chorionic Villus Sampling Set EchoTip® Disposable Two-Part Trocar Needle Skinny Needle® with Chiba Tip Percutaneous Entry Set Disposable Two-Part Trocar Needle Percutaneous Entry Set (EchoTip) EchoTip®Skinny Needle® with Chiba Tip Pursuit Balloon Dilation Catheter Ureteral Dilation Balloon Ascent AQ Ureteral Dilation Balloon Rhapsody® H-30® Holmium Laser System Cervical Mucus Aspiration Set Roadrunner Biliary Wire Guide ACROBAT CALIBRATED TIP WIRE GUIDE FUSION WIRE GUIDE LOCKING DEVICE DELTA WIRE GUIDE TRACER METRO DIRECT WIRE GUIDE ACROBAT 2 CALIBRATED TIP WIRE GUIDE ROADRUNNER WIRE GUIDE UroStream Hydrophilic Wire Guide STANDARD WIRE GUIDE Goldstein SonoBiopsy Catheter Flexipet, Adjustable Handle Set Replacement O-Ring Set Use With K-MPH-1000 Angled Tip Ureteral Catheter Set Angled Tip Ureteral Catheter Set With Bentson PTFE Wire Guide Angled Tip Ureteral Catheter with Bentson PTFE-Coated Wire Guide Pigtail Ureteral Catheter Set, Left Pigtail Ureteral Catheter With Sof-Flex® AQ® Pigtail Ureteral Catheter Set, Right Peel Away Introducer Stamey Percutaneous Loop TURP Suprapubic Catheter Set Percutaneous Malecot Nephrostomy Catheter Set Stamey Percutaneous Suprapubic Catheter Set Sof-flex Loop Suprapubic Catheter Set Margolin HSG Cannula Stonebreaker Pneumatic Lithotripter Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath with Radiopaque Stripe Ultraxx Nephrostomy Balloon with TFE Sheath TAO Brush I.U.M.C. Endometrial Sampler MADDURI URETERAL STONE PUSHING CATHETER Ultrathane Endoureterotomy Stent Set Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating Universa Firm Ureteral Stent Set with Hydrophilic Coating and Monofilament Tether Universa Firm Ureteral Stent Set with Hydrophilic Coating Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating and Monofilament Tether Check-Flo® Adapter with Side-Arm and Stopcock Tuohy-Borst Adapter Check-Flo® Adapter Endoscopic Cap Universal Check-Flo® Adapter Side-Arm Adapter - Male Luer Lock and Touhy-Borst Adapter Kwart Retro-Inject Ureteral Stent Set Soft-Pass Coaxial Insemination Catheter Shepard Intrauterine Insemination Catheter Insemi-Cath Pigtail Ureteral Catheter Set AQ Hydrophilic Dual Lumen Ureteral Access Catheter Cook Coagulator Probe Cook-Cope Loop Nephrostomy Catheter Ultrathane® Suprapubic Set With Mac-Loc® Ultrathane® Nephrostomy Set With Mac-Loc® Cook-Cope Loop Nephrostomy Set Two Part Needle Disposable Trocar Needle Percutaneous Entry Needle Offset Cervical Needle Fascial Incising Needle TFE Sheathed Needle Mitty Pollack Needle Set Aspiration Needle Set Skinny Needle Straight Forming Wire Holmium Laser Fiber Multi Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems Holmium Laser Fiber Single Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems Universa 2-Way Silicone Foley Catheter Universa 3-Way Silicone Folly Catheter Cook Fallopian Tube Catheterization Wire Guide with Platinum Tip Fallopian Tube Catheterization Set Kaye Nephrostomy Tamponade Balloon Catheter Set Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set Soft-Pass™ Embryo Mock Transfer Catheter Set with Echogenic Tip Soft-Pass™ Embryo Mock Transfer Catheter Set Gift Catheter Set Transmyometrial Embryo Transfer Catheter Embryo Transfer Catheter Intratubal Transfer Set Endosnare Endoscopic Splash Shield Silhouette® Transitionless Peel-Away® Introducer Jansen-Anderson Insemination Set Firlit-Sugar Intermittent Catheter Kish Urethral Illuminated Catheter Deflectable Biopsy Set Kidney Biopsy Brush Fair Urethral Stent Cook Cope Loop Suprapubic Catheter Set Tao Brush I.U.M.C. Endometrial Sampler Cook Cystostomy Catheter Set Safety Wire Guide Introducer Seidmon Antegrade AQ® Stent Set Arndt Airway Exchange Catheter Set with Rapi-Fit Adapters Aintree Intubation Catheter with Rapi-Fit Adapter Cook Airway Exchange Catheter with Rapi-Fit Adapters MAC-LOC MULTIPURPOS Bander Ureteral Diversion Stent Set Wire Guide With Hydrophilic Coating Bander Ureteral Diversion Open-End Stent Set Dretler Ureteroscopy Stent Set Bander Ureteral Diversion Stent Set Guardia Access Embryo Transfer Catheter Guardia AccessET Embryo Transfer Catheter Guardia Access Embryo Transfer Catheter With Internal Support Cannula Cystic Duct Introducer Set Flushing Catheter Guardia Obturator Malleable Adjustable Obturator Guardia Access Malleable Obturator Connecting Tube - Single Use With Cook Drainage Pouch Connecting Tube - Double Use With Cook Drainage Pouch Cook Drainage Pouch Set Flexi-Tip® Ureteral Catheter (Left) Round Tip Ureteral Catheter (Left) Open-End Ureteral Catheter Sof-Flex® Open-End Beveled Flexi-Tip® Ureteral Catheter Whistle Tip Ureteral Catheter (Left) Open-End Flexi-Tip® Ureteral Catheter Pediatric Ureteral Catheter Spiral Tip Ureteral Access Catheter Open-End Ureteral Catheter Flexi-Tip® Ureteral Catheter (Right) Echotip® Open-End Ureteral Catheter Whistle Tip Ureteral Catheter (Right) Whistle Tip Ureteral Catheter Round Tip Ureteral Catheter (Right)

Manufacture Medical Device Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)