Helix Medical, LLC

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Contact: Tom Vassallo - VP Marketing & Sales
Web: http://www.helixmed.com
E-Mail:
Address: 1110 Mark Avenue, Carpinteria, California 93013-2918, USA
Phone: +1-(805)-684-3304, 800-266-4421 | Fax: +1-(805)-684-1934 | Map/Directions >>

Profile: Helix Medical, LLC is a supplier of biocompatible silicone medical devices and components to the medical device, pharmaceutical & biotech industries. We specialize in tubings, stoppers and gaskets. Our HelixMark® stoppers are pharmaceutical grade silicone stoppers suitable for a tight, reliable seal when used with glass tubes, vials and flasks. These platinum-cured silicone stoppers have full traceability to raw materials, contain no peroxide catalysts and are autoclavable. Our HelixMark® braided reinforced silicone tubing can be sterilized by autoclave, ethylene oxide or gamma radiation within the user's validated cycles and exposure levels.

The company was founded in 1984, has revenues of USD 10-25 Million, has ~150 employees and is ISO 13485 certified.

FDA Registration Number: 2025182

23 Products/Services (Click for related suppliers)

• Braid/Coil Reinforced Tubing

• Braided Tubing

• Catheter Accessories (FDA Code: KGZ / 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.

• Close Tolerance Tubings

• Color Stripe Tubings

• Custom Extrusions

• Custom Molding

• Ear Wick (FDA Code: KCN / 874.5220)

An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

• Epistaxis Balloon (FDA Code: EMX / 874.4100)

An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.

• 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.

• Laryngeal Prosthesis (FDA Code: EWL / 874.3730)

A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.

• Measuring Gauge (FDA Code: JYJ / 874.4420)

• Medical Extrusions

• Nasal Snare (FDA Code: KBE / 874.4420)

• Nasopharyngeal Catheter (FDA Code: ENW / 874.4175)

A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilating the eustachian tube. This generic type of device includes eustachian catheters.

• Peristaltic Pump Tubings

• Seals & Gaskets

• Silicone Clamp Gaskets

• Silicone Stoppers

• Silicone Tubing

• Sinus Cannula (FDA Code: KAM / 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.

• Stopper

• Tubing