FDA Registration Active 🇺🇸 United States

Cook Incorporated

Reg #: 1820334 · FEI: 1820334 · Expires 2026
Products
202
Proprietary Names
479
Establishment Types
5
Classifications
202

Registration Details

Registration Name
Cook Incorporated
Registration Number
1820334
FEI Number
1820334
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
750 DANIELS WAY
City
Bloomington
State
IN
ZIP
47404
Country
US

Regulatory Submissions

510(k) Number
K013865
PMA Number
P100028

Owner / Operator

Firm Name
COOK, INC.
Operator Number
1820334
Address
750 DANIELS WAY
City
Bloomington
State
IN
Postal Code
47404
Country
US

Products

Device Name Product Code
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
Bag, Urine Collecting, Ureterostomy EXG
Guide, Surgical, Instrument FZX
Instrument, Manual, Specialized Obstetric-Gynecologic KNA
Catheter, Intravascular, Diagnostic DQO
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
Catheter, Percutaneous DQY
Tube, Bronchial (W/Wo Connector) BTS
Stents, Drains And Dilators For The Biliary Ducts FGE
Endoscopic Access Overtube, Gastroenterology-Urology FED
Catheter, Assisted Reproduction MQF
Cutter, Surgical FZT
Introducer, Catheter DYB
Instrument, Surgical, Disposable KDC
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Led Light Source NTN
Powered Laser Surgical Instrument GEX
Dilator, Vessel, For Percutaneous Catheterization DRE
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
Biopsy Needle FCG
Dilator, Catheter GCC
Catheter, Nephrostomy, General & Plastic Surgery GBO
Tray, Surgical LRP
Catheter, Urological KOD
Tubes, Gastrointestinal (And Accessories) KNT
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) HES
Catheter, Angioplasty, Peripheral, Transluminal LIT
Injector, Vertebroplasty (Does Not Contain Cement) OAR
Adaptor, Ureteral Catheter EYI
Needle, Catheter GCB
Set, Administration, Intravascular FPA
Catheter, Suprapubic (And Accessories) KOB
Catheter, Ureteral, Gastro-Urology EYB
Hysteroscope Accessories NWW
Cannula, Manipulator/Injector, Uterine LKF
Tube, Tracheal (W/Wo Connector) BTR
Stent, Ureteral FAD
Catheter, Percutaneous, Cutting/Scoring PNO
Dilator, Urethral KOE
Wire, Guide, Catheter DQX
Dilator, Catheter, Ureteral EZN
Device, Percutaneous Retrieval MMX
Intrauterine Tamponade Balloon OQY
Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
Tube Tracheostomy And Tube Cuff JOH
Endoscopic Injection Needle, Gastroenterology-Urology FBK
Lithotriptor, Electro-Hydraulic FFK
Syringe, Balloon Inflation MAV
Needle, Emergency Airway BWC
Tube, Gastro-Enterostomy KGC
System, Evacuator, Fluid FHF
Catheter, Irrigation GBX
Forceps, Biopsy, Non-Electric FCL
Forceps, Tube Introduction BWB
Hook, Gastro-Urology FHB
Instrument, Biopsy KNW
System, Applicator, Radionuclide, Manual IWJ
Endoscopic Cytology Brush FDX
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
Transducer, Ultrasonic JOP
Transducer, Ultrasonic, Diagnostic ITX
Flowmeter, Blood, Cardiovascular DPW
Connector, Airway (Extension) BZA
Microtools, Assisted Reproduction (Pipettes) MQH
Urinary Drainage Collection Kit, For Indwelling Catheter FCN
Evacuator, Gastro-Urology KQT
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Holder, Needle, Gastroenterologic FHQ
Device, Vascular, For Promoting Embolization KRD
Dislodger, Stone, Biliary LQR
Device, Cystometric, Hydraulic FEN
Unit, Filter, Membrane JRL
Catheter, Nephrostomy LJE
Feeding Tube Kit PRR
Stent, Renal NIN
Catheter, Embolectomy DXE
Microscope, Surgical, General & Plastic Surgery FSO
Brush, Biopsy, Bronchoscope (Non-Rigid) BTG
Instrument, Ent Manual Surgical LRC
Catheters, Salpingography MOV
Cannula, Injection FGY
Connector, Ureteral Catheter EYK
Device, Neurovascular Embolization HCG
Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
Laparoscope, General & Plastic Surgery GCJ
Ureteroscope And Accessories, Flexible/Rigid FGB
Image, Illumination, Fiberoptic, For Endoscope FFS
Kit, Nephroscope FGA
Cystoscope And Accessories, Flexible/Rigid FAJ
Tube, Tracheostomy (W/Wo Connector) BTO
Snare, Flexible FDI
Electrosurgical, Cutting & Coagulation & Accessories GEI
Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) NHC
Bottle, Collection, Vacuum KDQ
Retainer, Surgical GCZ
Catheter, Multiple Lumen GBP
Dislodger, Stone, Basket, Ureteral, Metal FFL
Connector, Catheter GCD
Catheter, Cholangiography GBZ
Mesh, Surgical FTM
Catheter, Continuous Flush KRA
Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
Device, Percutaneous, Biopsy MJG
Endoscope Channel Accessory ODC
Tourniquet, Nonpneumatic GAX
Trocar DRC
Adaptor, Catheter GCE
Catheter For Crossing Total Occlusions PDU
Catheter, Malecot FEW
Forceps, Wire Holding HYA
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Clamp, Penile FHA
Catheter, Balloon Type GBA
Cannula, Surgical, General & Plastic Surgery GEA
Sampler, Amniotic Fluid (Amniocentesis Tray) HIO
Tube, Tissue Culture KJG
Bronchoscope Accessory KTI
Cap, Cervical HDR
Syringe, Irrigating (Non Dental) KYZ
Stylet For Catheter, Gastro-Urology EZB
Collector, Ostomy EXB
Instrument, Catheter, Punch FEX
System, Endovascular Graft, Aortic Aneurysm Treatment MIH
Catheter, Hemodialysis, Non-Implanted MPB
Device, Incontinence, Urosheath Type, Non-Sterile NNX
Needle, Biopsy, Cardiovascular DWO
Brush, Biopsy, General & Plastic Surgery GEE
Endoscopic Guidewire, Gastroenterology-Urology OCY
Scissors, General, Surgical LRW
Dilator, Esophageal KNQ
Collector, Urine, Pediatric, For Indwelling Catheter FFH
Accessory, Assisted Reproduction MQG
Bougie, Urological FAX
Needle, Hypodermic, Single Lumen FMI
Holder, Ureteral Catheter EYJ
Catheter, Sampling, Chorionic Villus LLX
Retrograde Intubation Set QCX
Cannula, Intrauterine Insemination MFD
Instrument, Manual, Surgical, General Use MDM
Catheter, Urethral GBM
Brush, Endometrial HFE
Bag, Intestine KGY
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Screw, Fibroid, Gynecological HHO
Stylet, Surgical, General & Plastic Surgery GAH
Amniotome HGE
Forceps HTD
Knife, Surgical EMF
Needle, Tumor Localization MIJ
Surgical Instruments, G-U, Manual (And Accessories) KOA
Sound, Uterine HHM
Evacuator, Bladder, Manually Operated FFD
Endoscopic Cholangiogram Kit NWT
Prosthesis, Tracheal, Expandable JCT
Catheter And Tip, Suction JOL
Tubing, Noninvasive GAZ
Dilator, Lachrymal HNW
Filter, Intravascular, Cardiovascular DTK
Dilator, Cervical, Fixed Size HDQ
Stent, Bladder, Fetal MPR
Irrigator, Ostomy EXD
Accessories, Catheter KGZ
Carrier, Ligature GEJ
Tube, Aspirating, Flexible, Connecting BYY
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
Dilator, Tracheal KCG
Light, Catheter, Fiberoptic, Glass, Ureteral FCS
Cannula, Injector, Uterine, Endometrial Biopsy PGK
Aspirator, Endometrial HFF
Guide, Needle, Surgical GDF
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device FAP
Shield, Eye, Radiological IWS
Kit, Surgical Instrument, Disposable KDD
Catheter, Retention Type, Balloon EZL
Dispenser, Cement KIH
Needle, Assisted Reproduction MQE
Instrument, Ligature Passing And Knot Tying HCF
Laparoscopic Accessories, Gynecologic NWV
Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
Cement, Bone, Vertebroplasty NDN
Labware, Assisted Reproduction MQK
Stylet, Tracheal Tube BSR
Probe And Director, Gastro-Urology FGM
Tray, Surgical, Instrument FSM
Needle, Gastro-Urology FHR
Camera, Still, Surgical FTT
Catheter, Septostomy DXF
Needle, Aspiration And Injection, Disposable GAA
Laparoscope, Gynecologic (And Accessories) HET
Snare, Surgical GAE
Aspirator, Endocervical HFC
Filters, Cell Collection, Tissue Processing KET
Filiform And Filiform Follower FBW
Brush, Dermabrasion, Manual GED
Trocar, Gastro-Urology FBQ
Catheter, Peritoneal GBW
Mixer, Cement, For Clinical Use JDZ
Instrument, Surgical, Non-Powered HAO
Device, Biopsy, Endomyocardial DWZ
Shield, Protective, Personnel KPY
Micromanipulators And Microinjectors, Assisted Reproduction MQJ

Proprietary Names

Surgical Urine Drain Pouch Set Endoscopic Introducer/Extractor Pediatric Flexor Ureteral Access Sheath Gift Catheter Set Transmyometrial Embryo Transfer Catheter Embryo Transfer Catheter Intratubal Transfer Set Sling Cutter Liver Access and Biopsy Needle Set Liver Access and Biopsy Needle 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 Guardia Access Nano Embryo Transfer Catheter Cook CVC Triple Lumen Power-Injectable Central Venous Catheter Set Cook CVC Single Lumen Central Venous Catheter Set Cook Spectrum Turbo-Ject PICC Set Minocycline/Rifampin Impregnated Power Injectable Polyurethane Peripherally Inserted Central Venous Catheter Central Venous Catheter Tray Cook CVC Five Lumen Power Injectable Central Venous Catheter Tray Cook CVC Triple Lumen Power Injectable Central Venous Catheter Tray Cook CVC Five Lumen Power Injectable Central Venous Catheter Set Central Venous Catheter Set Cook CVC Double Lumen Power Injectable Central Venous Catheter Set Cook CVC Double Lumen Power Injectable Central Venous Catheter Tray MAC-LOC MULTIPURPOS Steam Sterilization Tray TFE Catheter Firlit-Sugar Intermittent Catheter Kish Urethral Illuminated Catheter Deflectable Biopsy Set Kidney Biopsy Brush Rutner Universal Wedge Catheter Fair Urethral Stent Cook Cope Loop Suprapubic Catheter Set Osteo-Force Connecting Tube Side Arm Adapter Foley Adapter/Connector Luer Lock Cap Disposable Stopcock Lymphangiography Catheter Lymphangiography Set Cook Cystostomy Catheter Set Flushing Catheter Guardia Obturator Malleable Adjustable Obturator Guardia Access Malleable Obturator Frova Intubating Introducer with Rapi-Fit Adapters Frova Intubating Introducer with Stiffening Cannula Sof-Flex, Double Pigtail Ureteral Stent Set Wire Guide with Hydrophilic Coating Black Silicone Filiform Dbl Pigtail Ureteral Stent Set Wire Guide With Hydrophilic Coating Black Silicone Filiform Double Pigtail Ureteral Stent Set Wire Guide With Hydrophilic Coating Micropuncture Pedal Access Set Silhouette Transitionless - with Nitinol Wire Guide and Hemostatic Valve Double Flexible Tipped Wire Guide UPJ Occlusion Balloon Catheter Set Urethral Dilator Set Bakri Essential Postpartum Balloon Gunther Tulip Vena Cava Filter Retrieval Set Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set Weinmann-Multi Tracheostomy Exchange Set Cook 810 Set Desilets-Hoffman Introducer Set Desilets-Hoffman Introducer Set With Radiopaque Band Elongated Cup Biopsy Forceps Cup Biopsy Forcepts Selikowtiz Ureteroscopic Knife Williams Cystoscopic Injection Needle Stonebreaker Pneumatic Lithotripter Cope Pediatric Gastrointestinal Suture Anchor Cope Pediatric Gastrointestinal Suture Anchor Set Enterostomy Suture Anchor Set Cook Collect Evac CATHETER INSERTION FORCEPS Aspiration Handle Osteo-Site® Bone Biopsy Needle Murphy M1M™ Osteo-Site® Bone Biopsy Needle Set Murphy M2™ Osteo-Site® Bone Biopsy Needle Murphy M2™ Osteo-Site® Bone Biopsy Needle Brush Biopsy Set Advance Biliary Balloon Catheter Pigtail Ureteral Catheter Set, Left Pigtail Ureteral Catheter With Sof-Flex® AQ® Pigtail Ureteral Catheter Set, Right Balloon Ureteral Dilator Set Balloon Ureteral Dilator Bentson Wire Guide 20cm Distal Flexibility with Softened Tip Heparin Coated Movable Core Wire Guide Tapered Tefcor Heparin Coated Rosen Curved Wire Guided Fixed Core Wire Guide Safe-T-J‚ Curved Fixed Core Wire Guide Straight Rosen Curved Wire Guide Heparin Coated Amplatz Extra Stiff Wire Guide Movable Core Wire Guide Tefcor Heavy Double Flexible Tipped Wire Guide TFE Coated Amplatz Ultra Stiff Wire Guide - Catheter Exchange TFE Coated Curved Amplatz Ultra Stiff Wire Guide - Catheter Exchange Amplatz Extra Stiff Wire Guide Heparin Coated Fixed Core Wire Guide Straight Heparin Coated Amplatz Extra Stiff Whisker Wire Guide Heparin Coated Fixed Core Bentson Curved Fixed Core Wire Guide Safe-T-J‚ Curved Heparin Coated Seidmon Antegrade AQ® Stent Set Hatter Flexible Cystoscopy Aspiration Tube Connecting Tube Cone Tip Ureteral Catheter with Open-End Cone Tip Ureteral Catheter NCompass® Nitinol Stone Extractor Silicone Rectal Balloon Sof-Flex® Double Pigtail Ureteral Stent Set Sof-Flex® Multi-Length Ureteral Stent 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 Guardia Access Embryo Transfer Catheter Guardia AccessET Embryo Transfer Catheter Guardia Access Embryo Transfer Catheter With Internal Support Cannula Laser Ureteral Catheter Kumpe Access Catheter Entuit Gastrostomy Set Entuit Gastrostomy Set with ENFit Connection Onik-Cohen Percutaneous Access Set Fiber Inspection Microscope Margolin HSG Cannula BRONCHIAL BRUSH BIOPSY SET BRONCHIAL BIOPSY BRUSH Modified Novy Cornual Cannulation Set Emergency Transtracheal Airway Catheter Endovascular Dilator Endovascular Dilator and Set Endovascular Dilator Set Coons Dilator Endovascular Dilator Coons Dilator Universal Check Flo Adapter Female Luer Lock Cap Dual Male Luer Lock Adapter Dual Check Valve Anesthetic Gel Adapter Endoscopic Tuohy Borst Adapter Peel Away Introducer Royal Flush Plus High-Flow Catheter Ball Tip Fulgurating Electrode Flexor Vision VersaTube Tapered Tracheostomy Tube with Disposable Inner Ca Rosch-Uchida Transjugular Liver Access Set Ring Transjugular Intrahepatic Access Set Needle Catheter Combination Stylet Catheter Combination Greene Renal Transplant Stent Set Wire Guide With Hydrophilic Coating Endosnare Cook Coagulator Probe VentriClear II Ventricular Drainage Catheter Nathanson Transcystic Bile Duct Stone Exploration Pack Peel-Away® Introducer Set Peel-Away® Introducer Arterial Pressure Monitoring Tray Arterial Pressure Monitoring Set Urethane Arterial Pressure Monitoring Set Arterial Pressure Monitoring Set Nylon Check-Flo Performer Introducer Retracta Detachable Embolization Coil Tissue Bag Introducer FUSION LITHOTRIPSY EXTRACTION BASKET MEMORY SOFT WIRE BASKET MEMORY HARD WIRE BASKET THE WEB EXTRACTION BASKET Cystic Duct Introducer Set Surgisis and Surgisis ES 1,4 Layer Tissue Graft Roadrunner Extra Support Wire Guide Ring Biliary Drainage Set Amplatz Universal Drainage Catheter Ultrathane Ring Biliary Duct Drainage Catheter Polyethylene Biliary Drainage Catheter Ultrathane San Antonio Stopcock TIGER TOURNIQUET CATHETER ACCESSORIES Approach® CTO Micro Wire Guide Extra Large Check-Flo Introducer Kaye Nephrostomy Tamponade Balloon Catheter Set Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set Royal Flush® Catheter Micropuncture® Introducer Set Silhouette® Transitionless With Stainless Steel Wire Guide Micropuncture® Introducer Set With Cope Platinum-Tipped Stainless Steel Wire Guide Micropuncture® Introducer Set Silhouette® Transitionless Push-Plus™ Design With Nitinol Wire Guide Micropuncture® Introducer Set Silhouette® Transitionless Push-Plus™ Design - STIFFENED CANNULA With Nitinol Wire Guide Micropuncture® Introducer Set Silhouette® Transitionless With Cope Platinum-Tipped Stainless Steel Wire Guide Micropuncture® Introducer Set With Stainless Steel Wire Guide Micropuncture® Pedal Access Set Silhouette® Transitionless - with Nitinol Wire Guide and Hemostatic Valve Micropuncture® Introducer Set Silhouette® Transitionless With Platinum-Tipped Stainless Steel Wire Guide Micropuncture® Introducer Set Silhouette® Transitionless With Nitinol Wire Guide Micropuncture® Introducer Set With Nitinol Wire Guide Micropuncture® Introducer Set Silhouette® Transitionless Design with Nitinol Wire Guide and EchoTip® Needle Micropuncture® Introducer Set Silhouette® Transitionless Push-Plus™ Design - STIFFENED CANNULA With Stainless Steel Wire DILATOR WITH AQ® HYDROPHILIC COATING NYLON DILATOR Flexor Ureteral Access Sheath with AQ Hydrophilic Coating Flexor Parallel Rapid Release Ureteral Access Sheath with AQ Hydrophilic Coating Roadrunner PC Wire Guide Nimble Floppy Roadrunner PC Wire Guide The Firm Roadrunner PC Wire Guide Nimble Roadrunner PC Wire Guide The Firm LT Cook-Cope Loop Nephrostomy Catheter Ultrathane® Suprapubic Set With Mac-Loc® Ultrathane® Nephrostomy Set With Mac-Loc® Cook-Cope Loop Nephrostomy Set CAGED BALLOON CATHE 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 One-Step Suprapubic Introducer Labcath Advance, 14LP Low Profile PTA Balloon Dilatation Catheter Cook Retrograde Intubation 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 Multi-Sideport Catheter Infusion Set Dual Check Valve Non-Toxic Syringe Vacuum Syringe Taylor Gel Adapter Straight Forming Wire Holmium Laser Fiber Connecting Tube - Single Use With Cook Drainage Pouch Connecting Tube - Double Use With Cook Drainage Pouch Cook Drainage Pouch Set ZENITH® AAA ILIAC PLUG WITH THE H&L-B ONE SHOT¿ INTRODUCER SYSTEM Percutaneous Neonatal Pigtail Nephrostomy Set Pediatric Nephrostomy Stent Set Polyethylene Catheter McLean-Ring Nasojejunal Feeding Tube Set Amplatz Ultra Stiff Wire Guide Newton Wire Guide LT Taper Newton Wire Guide LLT Taper Coons Interventional Wire Guide Amplatz Stiff Wire Guide Lunderquist-Ring Torque Wire Guide Newton Cerebral Wire Guide LLT Fixed Core Bentson Curved Wire Guide Fixed Core Wire Guide Safe-T-J Curved Wire Guide Bentson Wire Guide Amplatz Extra Stiff Whisker Wire Guide Rosen Curved Wire Guide HERCULES 3 STAGE BALLOON ESOPHAGEAL HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL - PYLORIC - COLONIC Cook Aspiration Unit 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 Urethral Meatal Dilator Cook Chorionic Villus Sampling Set Pakter Curved Needle Set Dieckmann Intraosseous Infusion Needle 45 Degree Trocar - Pediatric Use (Less than 24 months) Dieckmann Intraosseous Infusion Needle 45 Degree Trocar Novy Corneal Cannulation Set Retrograde Intubation Set Jansen-Anderson Insemination Set Insemi-Cath Arterial Pressure Monitoring Tray Nylon Micropuncture Introducer Set Silhouette Transitionless With Cope Platinum-Tipped Stainless Steel Wire Guide Micropuncture Introducer Set Silhouette Transitionless Push-Plus Design - STIFFENED CANNULA With Stainless Steel Wire Guide Micropuncture Introducer Set Silhouette Transitionless Micropuncture Introducer Set Push-Plus Design STIFFENED CANNULA With Stainless Steel Wire Guide Micropuncture Introducer Set With Nitinol ST Wire Guide Micropuncture Introducer Set Silhouette Transitionless Design with Nitinol Wire Guide and EchoTip Needle Micropuncture Introducer Set Silhouette Transitionless With Stainless Steel Wire Guide Micropuncture Introducer Set With Cope Platinum-Tipped Stainless Steel Wire Guide Micropuncture Introducer Set Silhouette Transitionless Push-Plus Design - STIFFENED CANNULA With Nitinol Wire Guide Micropuncture Introducer Set Push-Plus Design - STIFFENED CANNULA With Nitinol Wire Guide Micropuncture Introducer Set Silhouette Transitionless With Platinum-Tipped Stainless Steel Wire Guide Micropuncture Introducer Set Silhouette Transitionless With Nitinol Wire Guide Micropuncture Introducer Set With Nitinol Wire Guide Micropuncture Introducer Set With Stainless Steel Wire Guide Check-Flo Introducer Koyle Diaper Stent Zaontz Urerthral Stent Firlit-Kluge Urethral Stent Aurous Centimeter Sizing Catheter White Sizing Catheter Deflectable Brush Biopsy Set Tao Brush I.U.M.C. Endometrial Sampler 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 Hilal Embolization Coil Cook Fallopian Tube Catheterization Wire Guide with Platinum Tip Fallopian Tube Catheterization Set Laparoscopic Myoma Screw Hysteroscopic Myoma Screw Malecot Nephrostomy Catheter/Stent Set Lunderquiest Transhepatic Set Guided Biliary Dilator Set Common Bile Duct Stent Set Laparoscopic Miller Double Mushroom Biliary Stent Set Safety Wire Guide Introducer Rhapsody® H-30® Holmium Laser System Lumax® Guiding Catheter/Guiding Coaxial Design Lumax® Guiding Catheter N-Snare Stent Retriever Ureteral Meatotomy Knife Reuter Tip Deflecting Wire Guide Disposable Reuter Tip Deflecting Wire Guide Soft-Pass™ Embryo Mock Transfer Catheter Set with Echogenic Tip Soft-Pass™ Embryo Mock Transfer Catheter Set Initial Placement Gastrostomy Set Check-Flo Performer Introducer Set Micropuncture® Radial Artery Access CHIBA DECOMPRESSION SET OBrien Suprapubic Peel-Away® Access Set Cook® SP Tube Introducer Set TriForce Peripheral Crossing Set Entuit Secure Gastrointestinal Suture Anchor Set Entuit Secure Adjustable Gastrointestinal Suture Anchor Set Foot Ureteroscopy Irrigation Pump Ureteroscopy Irrigation System Pediatric Urological Drain Bag Common Bile Duct Exploration Set Connecting Tubes and Pressure Monit Filler Tubes, Various Gianturco Roehm Bird's Nest Vena Ca Disposable Cervical Dilators Silhouette® Transitionless Peel-Away® Introducer Aspiration Tube Connecting Tubes CIAGLIA BLUE RHINO PERCUTAN Flexor, Shuttle - SL Introducer with Tuohy-Borst Sidearm Flexor, Tuohy-Borst Side-Arm Introducer Shuttle,-SL Soules Intrauterine Insemination Catheter CXI Support Catheter Lawson Retrograde Nephrostomy Wire Puncture Set Australian Mandril Wire Guide Pigtail Ureteral Catheter Set AQ Hydrophilic Dual Lumen Ureteral Access Catheter Goldstein SonoBiopsy Catheter Ring Biliary Duct Drainage Catheter Ultrathane Cope Proximal Biliary Loop Catheter Ultrathane Cope Proximal Biliary Loop Catheter Ultrathane, Cook Silicone Balloon HSG Catheter Cook Silicone Balloon HSG Catheter With Closed End And Sideport Markham Flexible Needle Guide Fuchs Endo-Needle Guide Endoscopic Curved Needle Holder Amplatz Needle Holder CODA BALLOON CATHETER 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 COONS DILATOR COPE INTRODUCING DILATOR ENDOVASCULAR DILATOR SET DILATOR SET AQ HYDROPHILIC COATED DILATOR DILATOR MADDURI URETERAL STONE PUSHING CATHETER Holmium Laser Safety Goggles and Glasses Amplatz Renal Dilator Set Gastric Sizing Balloon Catheter EMBO PREP KIT 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 Ultraxx Nephrostomy Balloon Set Ultraxx Nephrostomy Balloon Set with TFE Sheath Bunegin-Albin Air Aspiration Set Polyethylene Salle Intraoperative Pyeloplasty Stent Set With 6cm Stylet Salle Intraoperative Pyeloplasty Stent Set With 3cm Stylet Ovum Aspiration Needle Ovum Aspiratiaon Needle with AQ Coating Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath with Radiopaque Stripe Ultraxx Nephrostomy Balloon with TFE Sheath Selective Salpingography Catheter Intrauterine Access Balloon Catheter Knot Pusher Nester Embolization Coil Tornado Embolization Coil Tornado Embolization Microcoil Micronester Embolization Coil Injekt Filiform Injection Needle Cook Injection Needle Odyssey Holmium Laser System Nest VT Vitrification Device Amplatz Ureteral Stent Set Ultrathane Cope Nephroureterostomy Stent Ultrathane Arndt Airway Exchange Catheter Set with Rapi-Fit Adapters Aintree Intubation Catheter with Rapi-Fit Adapter Cook Airway Exchange Catheter with Rapi-Fit Adapters Ultrathane Endoureterotomy Stent Set Cope Gastrojejunostomy Cannula Vas Reapproximator Set Cook Sterilization Case MReye Embolization Coil Endogo HD MagniCore Precision Chiba iMRI Needle MagniCore Precision Coaxial iMRI Needle Black Silicone Filiform Double Pigtail Ureteral Stent Set Ureteral TFE Dilator Set Ureteral Dilator Ureteral Dilator With AQ, Hydrophilic Coating With Modified Taper Ureteral Dilator With AQ, Hydrophilic Coating Ureteral Dilator Set Dilators With AQ, Hydrophilic Coating Ureteral TFE Dilator Ureteral Dilator Set Stamey Percutaneous Loop TURP Suprapubic Catheter Set Percutaneous Malecot Nephrostomy Catheter Set Stamey Percutaneous Suprapubic Catheter Set Sof-flex Loop Suprapubic Catheter Set COOK Strange Bile Duct Stone Exploration Set Universa 2-Way Silicone Foley Catheter Universa 3-Way Silicone Folly Catheter Kwart Retro-Inject Ureteral Stent Set 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 Cook Turbo-Flo HD Hemodialysis Catheter Tray Double Lumen Polyurethane Cook Turbo-Flo HD Hemodialysis Catheter Tray Double Lumen Polyurethane Catheter Cook Turbo-Flo HD Hemodialysis Catheter Set Double Lumen Polyurethane Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous 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) Amplatz Support Wire Guide with Apex Curve Amplatz Renal Introducer Amplatz Radiopaque TFE Sheath Catheter for Use with Amplatz Renal Dilator Set Clear Amplatz Sheath with Radiopaque Stripe Amplatz Dilator Cook® Spectrum® Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated Power Injectable Triple Lumen Spectrum Central Venous Tray Triple Lumen Polyurethane Catheter Minocycline/Rifampin Impregnated Spectrum Central Venous Catheter Set Double Lumen Polyurethane Minocycline/Rifampin Antibiotic Impregnated Spectrum Central Venous Tray Five Lumen Polyurethane Catheter Minocycline/Rifampin Impregnated Cook Spectrum Central Venous Catheter Tray Power Injectable Double Lumen Minocycline/Rifampin Antibiotic Impregnated Cook Spectrum Central Venous Catheter Tray Power Injectable Triple Lumen Minocycline/Rifampin Antibiotic Impregnated Spectrum Central Venous Catheter Set Triple Lumen Polyurethane Minocycline/Rifampin Antibiotic Impregnated Wittich Nitinol Stone Basket Arndt Pediatric Endobronchial Blocker Set With Spherical Balloon Turbo-Flo PICC Set Polyurethane Peripherally Inserted Central Venous Catheter Weinmann Tracheostomy Exchange 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 Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter Spectrum Central Venous Tray Double Lumen Polyurethane Catheter Minocycline/Rifampin Impregnated Pursuit Balloon Dilation Catheter Ureteral Dilation Balloon Ascent AQ Ureteral Dilation Balloon Endoscopic Splash Shield Flexipet, Adjustable Handle Set Replacement O-Ring Set Use With K-MPH-1000

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility Sterilize Medical Device for Another Party (Contract Sterilizer)