Sterigenics Us Llc

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Contact: Stacey Mcswine
Web: http://www.sterigenics.com/usa.htm
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Address: 10811 Withers Cove Park Drive, Charlotte, North Carolina 28278, USA
Phone: +1-(630)-928-1787 | Map/Directions >>

Profile: Sterigenics Us Llc provides contract sterilization solutions to the medical device and pharmaceutical industries, using ethylene oxide, gamma and electron beam irradiation. Our labs offer a comprehensive range of microbiological and analytical testing services designed to optimize processing speed. Validation services are also available to verify testing procedures.

FDA Registration Number: 1058584

11 Products/Services (Click for related suppliers)

• Contract Sterilization

• Contract Sterilization Services

• Disposable Surgical Instrument Kit (FDA Code: KDD / 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.

• Elastic Bandages (FDA Code: FQM / 880.5075)

An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.

• Laboratory Testing Services

• Manual Gastro-Urology Surgical Instrument (FDA Code: KOA / 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.

• Microsurgical Instruments (FDA Code: GZX / 882.4525)

A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

• Pharmaceutical Sterilization

• Sterile Specimen Container (FDA Code: FMH / 864.3250)

A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Suction Catheter and Tip (FDA Code: JOL / 880.6740)

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Tissue Culture Flask (FDA Code: KJA / 864.2240)

Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.