Profile: Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical devices and orthopedic surgical instruments. Our OEM brands include Beere Medical, KMedic, Deknatel and TFX OEM. We have extensive expertise in the cardiovascular, orthopedic, spinal, urology, gynecology & minimally invasive surgical specialties. Our Taut® ADAPt product line, with the addition of the universal seal ports, offers surgeons a completely bladeless laparoscopic access. The universal seal is a new approach to access for the wide variety of instruments needed in laparoscopic surgery. It provides surgeons the ability to perform procedures without torn seals, smudged cameras or the need for reducer caps. Our Arrow Pressure Injectable Triple-Lumen PICC has the ability to pressure-inject contrast media. In addition, it has central venous pressure monitoring (CVP) indication, clear and useful product labeling, a non-tapered catheter body for reduced risk of vessel occlusion, & the unique Arrow Blue FlexTip®. It is also indicated for central venous pressure monitoring, as a valuable tool for monitoring critically ill patients.

The company has revenues of USD 50-100 Million, has ~380 employees and is ISO 9001, CE certified. NYSE:TFX (SEC Filings)

FDA Registration Number: 1044475

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• Forceps (FDA Code: HTD / 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.

• Fork (FDA Code: HXE / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Frontal-Sinus Rasp (FDA Code: KAZ / 874.4420)

• Gallstone Scoop (FDA Code: FHL / 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.

• 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.

• Gas Mask Head Strap (FDA Code: BTK / 868.5560) A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face.

• Gaseous Phase Carbon-Dioxide Gas Analyzer (FDA Code: CCK / 868.1400) A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

• Gaseous Phase Oxygen Gas Analyzer (FDA Code: CCL / 868.1720) An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

• Gastro-Urology and Gastrointestinal Esophageal Bougie (FDA Code: FAT / 876.5365) An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

• Gastro-Urology Endoscopic Injection Needle (FDA Code: FBK / 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.

• Gastro-Urology Evacuator (FDA Code: KQT / 876.4370) A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.

• Gastro-Urology Probe and Director (FDA Code: FGM / 876.4730)

• Gastro-Urology Rigid Esophagoscope (FDA Code: FDW / 876.1500)

• Gastro-Urology Tourniquet (FDA Code: EYR / 878.5900) A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.

• Gastroenterologic Needle Holder (FDA Code: FHQ / 876.4730)

• Gastrointestinal Tube and Accessories (FDA Code: KNT / 876.5980) A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)

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

• General & Plastic Surgery Mirror (FDA Code: FTX / 878.4800)

• General & Plastic Surgery Nephrostomy Catheter (FDA Code: GBO / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800)

• General & Plastic Surgery Surgical Clamp (FDA Code: GDJ / 878.4800)

• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800)

• General & Plastic Surgery Surgical Elevator (FDA Code: GEG / 878.4800)

• General & Plastic Surgery Surgical File (FDA Code: GEO / 878.4800)

• General & Plastic Surgery Surgical Gouge (FDA Code: GDH / 878.4800)

• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800)

• General & Plastic Surgery Surgical Mallet (FDA Code: GFJ / 878.4800)

• General & Plastic Surgery Surgical Rasp (FDA Code: GAC / 878.4800)

• General & Plastic Surgery Surgical Spatula (FDA Code: GAF / 878.4800)

• General Cannulas

• General Diagnostic Supplies

• General Manual Obstetric/Gynecologic Instrument (FDA Code: KOH / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• General Medical Supplies

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• General Surgical Scissors (FDA Code: LRW / 878.4800)

• General Sutures/Needles

• General Tubing

• General use Surgical Curettes (FDA Code: FZS / 878.4800)

• Guidewire Catheter (FDA Code: DQX / 870.1330) A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

• Guiding Probes

• Gynecological Biopsy Forceps (FDA Code: HFB / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Gynecological Cerclage Needle (FDA Code: HDH / 884.4530)

• Gynecological Fibroid Hook (FDA Code: HDE / 884.4520)

• Gynecological Surgical Forceps (FDA Code: HCZ / 884.4530)

• Heart Stabilizer (FDA Code: MWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

• Heat and Moisture Condenser (FDA Code: BYD / 868.5375) A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

• Hemorrhoidal Ligator (FDA Code: FHN / 876.4400) A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

• Hemostatic Clip Applier (FDA Code: HBT / 878.4800)

• Hemostats (FDA Code: HRQ / 878.4800)