Profile: CIVCO Medical Solutions designs, manufactures & distributes medical products for ultrasound and minimally invasive surgical equipment & procedures. Our clinical specialties are radiation oncology, general imaging radiology, women's healthcare, urology, cardiology, vascular and emergency medicine. Our endocavity covers are latex made or latex free. Our NeoGuard™ is a rolled, latex-free endocavity cover material specially designed for ultrasound use. It is recommended for patients and professionals with latex protein sensitivities. These high-quality covers are available for popular endocavity transducers and include colored elastic bands. Our AccuCARE™ disposable template grids are for use during brachytherapy and 3D pathologic mapping of the prostate. They consist of rows and columns of holes spaced 5mm apart, providing accurate placement of radioactive seeds in predefined areas of the prostate.

The company was founded in 1981, has ~120 employees and is ISO 9001, CE certified.

FDA Registration Number: 1937223

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• Anatomical Training Model

• Brain Biopsy Needle Guides

• Cardiovascular Biopsy Needle (FDA Code: DWO / 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.

• Densitometers (FDA Code: DXM / 870.1450) A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood.

• Diagnostic Ultrasonic Transducer (FDA Code: ITX / 892.1570) A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

• Dialysis Holding Tank (FDA Code: FIN / 876.5820) A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

• Disposable Surgical Drape (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Endocavity Needle Guides

• Endomyocardial Biopsy Device (FDA Code: DWZ / 870.4075) An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.

• Frameless Stereotactic CT Guided Needle Guides

• 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.

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

• General Surgery Supplies

• Guiding Probes

• Intensity Modulated Radiation Therapy Accessories

• Laparoscopic Probes

• Laser Power Probe

• Liquid Disinfector

• Low Voltage Therapeutic X-Ray Generator (FDA Code: IYD / 892.5900) An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

• Mattress Cover (FDA Code: FMW / 880.6190) A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide.

• 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 Probes (FDA Code: HXB / 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.

• Medical Ultrasound Devices

• Needle Guide

• Needle Guide Accessories

• Needle Guides & Guidance Systems

• Needles & Needle Guides

• Non-Powered Communication System (FDA Code: ILP / 890.3700) A nonpowered communication system is a mechanical device intended for medical purposes that is used to assist a patient in communicating when physical impairment prevents writing, telephone use, reading, or talking. Examples of nonpowered communications systems include an alphabet board and a page turner.

• Operating Room Shoe Cover (FDA Code: FXP / 878.4040) Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

• Operating-Room Table and Attachments (FDA Code: BWN / 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.

• Paper Towel/Towelette

• Periodontal Probes

• Positioning System Accessories

• Printer Accessories

• Printers

• Probes (FDA Code: HXB / 888.4540)

• Probes (FDA Code: HXB / 888.4540)

• Radiation Oncology Device Accessories

• Radiation Therapy Accessories

• Radiographic Film (FDA Code: IWZ / 892.1840) Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.

• Radiographic Film Marking X-Ray System (FDA Code: JAC / 892.1640) A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.

• 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.

• Radionuclide Brachytherapy Source (FDA Code: KXK / 892.5730) A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

• Reusable Aspiration and Injection Needle (FDA Code: GDM / 878.4800)

• Stationary Top Radiographic Table (FDA Code: IXQ / 892.1980) A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.

• Sterile Surgical Drapes (FDA Code: KKX / 878.4370)

• Surgical Drapes (FDA Code: KKX / 878.4370)

• Surgical Drapes & Packs (FDA Code: KKX / 878.4370)

• Transducer Probe Cover

• Ultrasonic Obstetric-Gynecologic Imager (FDA Code: HEM / 884.2225) An obstetric-gynecologic ultrasonic imager is a device designed to transmit and receive ultrasonic energy into and from a female patient by pulsed echoscopy. This device is used to provide a visual representation of some physiological or artificial structure, or of a fetus, for diagnostic purposes during a limited period of time. This generic type of device may include the following: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, coupling gel, and component parts. This generic type of device does not include devices used to monitor the changes in some physiological condition over long periods of time.