Profile: Cardinal Health is a manufacturer and distributor of medical & surgical supplies. Our clinical and medical products segment manufactures medication infusion & dispensing products, respiratory equipment, and surgical instruments. We offer leading technologies and services that help hospitals prevent medication errors, reduce infections and manage medications & supplies more efficiently. We offer V. Mueller® and Snowden-Pencer® minimally invasive surgical instruments. Our Snowden Pencer products include tungsten carbide instrument, carbide scissors, forceps, bone rasps and serrated scissors. All our surgical instruments are hand crafted. Our gator-toothed grasper is a laparoscopic product, which has a reverse angled tooth providing aggressive grip of tissue. The jaw is cupped to allow tissue to herniate when compressed & this is ideal for pelviscopy and for handling fibrous ovaries & uterine tissue.

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• Data Processing Module for Clinical use (FDA Code: JQP / 862.2100) A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data.

• Dental Exam Gloves

• Digital Mammography Systems

• Direct Patient Interface Respiratory Gas Humidifier (FDA Code: BTT / 868.5450) A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

• Disposable Anesthesia Breathing Masks

• Disposable Coveralls

• Disposable Extension Tubing

• Disposable Eye Shield

• Disposable Eye-Shields

• Disposable Face Shields

• Disposable Gown Dispenser

• Disposable Nasopharyngeal Airways

• Disposables

• Disposables Products

• Dosimetry Kit

• Double-Strap N95 Respirators

• Drainage Bag

• Dual Lumen Catheter

• Earloop Fluid-Resistant Masks

• Elastomeric Ambulatory Infusion System

• Electronic Thermometer

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Electrosurgical Electrode (FDA Code: JOS / 878.4400)

• Endobronchial Tubes

• Endoscope Accessories (FDA Code: KOG)

• Endoscopes

• Endoscopes

• Endoscopic Video Imaging System/Component (FDA Code: FET / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Endotracheal Tube Guides

• Endotracheal Tube Holders

• ENT Manual Surgical Instrument (FDA Code: LRC / 874.4420)

• Enteral Irrigation Kit w/Piston Syringe

• Extension Tubes

• Fabric-Reinforced Surgical Gowns

• Female Catheters

• Female Urethral Catheterization Kit

• Fiberoptic Retractor (FDA Code: FDG / 876.4530) A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.

• Flexible Tracheostomy Tubes

• Fluid-Resistant Molded Surgical Masks

• Fluid-Resistant Surgical Gowns

• Fog-Inhibiting Surgical Masks

• Foley Catheter Holders (FDA Code: EYJ / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Foley Catheterization Trays

• Foley Catheters

• Forceps Needle Holders

• Garments

• Gas Cylinder Pressure Regulator (FDA Code: CAN / 868.2700) A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

• Gastroenterologic Needle Holder (FDA Code: FHQ / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)