Profile: Steris Corporation offers a wide range of infection protection & contamination control products, including sterile processing solutions, surgical equipment such as surgical lights & tables, and laboratory medical equipment. Our cmax operating table combines all the positioning capabilities of a general surgical table with the radiolucence and precise mobility of an imaging table, making it an advanced & versatile surgical table. Our hausted youth care stretcher is a full size stretcher for young children and adolescents with the security of vertical rails. Our Amsco warming cabinet is designed to raise the temperature of surgical irrigation solutions and/or blankets to an acceptable level for hospital & surgical outpatient center applications.
The company was founded in 1987, has revenues of > USD 1 Billion, has ~5100 employees and is ISO 9001, CE certified. NYSE:STE (SEC Filings)
FDA Registration Number: 1527821
• Liquid Disinfector |
• Manual Operating Room Table (FDA Code: FSE / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures. |
• Manual Patient Transfer Device (FDA Code: FMR / 880.6785) A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher. |
• Medical Device, Disinfector (FDA Code: MEC / 880.6992) A medical washer-disinfector is a device that is intended for general medical purposes to clean, decontaminate, disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices. |
• Medical Device, Sterilant (FDA Code: MED / 880.6885) A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin. |
• Medical Devices, Disinfectant (FDA Code: LRJ / 880.6890) A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin. |
• Medical Instrument Ultrasonic Cleaner (FDA Code: FLG / 880.6150) An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves. |
• Medical Training Service |
• Millipore Water Purification Systems |
• Miscellaneous Deodorizers |
• Obstetrical Table and Accessories (FDA Code: KNC / 884.4900) An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes. |
• Operating Room Equipment Table Extensions |
• Operating Room Scrub Brush (FDA Code: GEC / 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. |
• Operating-Room Electrical Table (FDA Code: GDC / 878.4960) Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient. |
• Operating-Room Table and Attachments (FDA Code: BWN / 878.4950) |
• Ophthalmology, Surgical Instrument Tables |
• OR Tables |
• Orthopedic Surgical Table and Accessories (FDA Code: JEB / 878.4950) |
• Oxygen Tents (FDA Code: BYL / 868.5700) A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods. |
• Patient Scale (FDA Code: FRW / 880.2720) A patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scale. This generic device includes devices placed under a bed or chair to weigh both the support and the patient, devices where the patient is lifted by a sling from a bed to be weighed, and devices where the patient is placed on the scale platform to be weighed. The device may be mechanical, battery powered, or AC-powered and may include transducers, electronic signal amplification, conditioning and display equipment. |
• Pediatric Hospital Bed (FDA Code: FMS / 880.5140) A pediatric hospital bed is a device intended for medical purposes that consists of a bed or crib designed for the use of a pediatric patient, with fixed end rails and movable and latchable side rails. The contour of the bed surface may be adjustable. |
• Physical/Chemical Sterilization Process Indicator (FDA Code: JOJ / 880.2800) A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. |
• Pneumatic Operating Room Table (FDA Code: FWW / 878.4960) |
• Portable Fracture Table |
• Powered Wheeled Stretcher (FDA Code: INK / 890.3690) A powered wheeled stretcher is a battery-powered table with wheels that is intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions). |
• Programmable Autoclaves |
• Radiographic Grid (FDA Code: IXJ / 892.1910) A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor. |
• Radiological Digital Image Communication System (FDA Code: LMD / 892.2020) A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. |
• Replacement Bulbs |
• Skin Creams & Lotions |
• Soap & Soap Dispensers |
• Solar Powered Water Purification Systems |
• Steam Sterilizers (FDA Code: FLE / 880.6880) A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam. |
• Sterile Irrigation Tray (FDA Code: EYN / 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). |
• Sterilization Indicators (FDA Code: LRT / 880.2800) |
• Sterilization Wrap (FDA Code: FRG / 880.6850) A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. |
• Sterilization Wrap Containers (FDA Code: KCT / 880.6850) |
• Sterilizers & Autoclaves |
• Surface Disinfectants |
• Surgical Equipment |
• Surgical Equipment |
• Surgical Exhaust Apparatus (FDA Code: FYD / 878.5070) Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient. |
• Surgical Instrument Table |
• Surgical Lamps (FDA Code: FTD / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient. |
• Surgical Lights (FDA Code: FTD / 878.4580) |
• Surgical Scrubs & Cleansers |
• Table Extensions |
• Test Equipment & Biomedical Devices |
• Thermal Infusion Fluid Warmer (FDA Code: LGZ / 880.5725) |
• Top Loading Autoclaves |