Profile: Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family planning, general examination, cervical care, incontinence products, surgical and neonatal products. Some of our products are vacuum assist delivery devices, antepartum fetal monitors, fetal dopplers, colposcopy systems, and colposcopy instruments. Our Mityvac® line of obstetrics products are reusable and reposable. Our MityVac® is based on the reusable MityVac® pump, with a variety of disposable cup configurations. The FetalGard Lite®, is a powerful and flexible system for monitoring fetal heart rate & pressure, critical to healthy outcomes for mother &child. The optional remote care through FetalGard Lite® view software, allows communication with the computer network.
The company was founded in 1990, has revenues of USD 100-500 Million, has ~430 employees and is ISO 9001, CE certified. NYSE:COO (SEC Filings)
FDA Registration Number: 1216677
• Pulmonary Function Data Calculator (FDA Code: BZC / 868.1880) A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing. |
• 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. |
• Radiological Digital Image Storage Device (FDA Code: LMB / 892.2010) A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory. |
• Rectal Dilator (FDA Code: FFP / 876.5450) A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument. |
• Reproductive Media (FDA Code: MQL / 884.6180) Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.). |
• Reusable Bell Vacuum Cup |
• Reusable Vacuum Hand Held Pump |
• Rotating Biopsy Punches |
• SAPA Colposcope |
• Sexual Assault Colposcope |
• Single-Bottle Gel Warmer |
• Single-Incision Filshie Clip Applicator |
• Specialized Obstetric-Gynecologic Manual Instrument (FDA Code: KNA / 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: |
• Standard Gel Warmer |
• Sterile Surgical Drapes (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. |
• Straight Uterine Curette w/Regular Tip |
• Surgical Curette (FDA Code: FZS / 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. |
• Surgical Drapes (FDA Code: KKX / 878.4370) |
• Surgical Drapes & Packs (FDA Code: KKX / 878.4370) |
• Surgical Retractor (FDA Code: GAD / 878.4800) |
• Surgical Retractor Systems (FDA Code: GAD / 878.4800) |
• Surgical Still Camera (FDA Code: FTT / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures. |
• Surgical Stylet (FDA Code: GAH / 878.4800) |
• Surgical Television Camera without Audio (FDA Code: FWB / 878.4160) |
• Thermasonic Gel Warmer |
• Three-Bottle Gel Warmer |
• Tracheal Tube Fixation Device (FDA Code: CBH / 868.5770) A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings. |
• Tracheobronchial Suction Catheter (FDA Code: BSY / 868.6810) A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway. |
• Ultrasonic Fetal Monitor (FDA Code: KNG / 884.2660) A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value. |
• Ultrasonic Gel Warmer |
• Ultrasonic Puls-Echo Scanner (FDA Code: IYO / 892.1560) An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. |
• Ultrasonic Transmission Gel |
• Ultrasound Bone Analyzer |
• Upright Post Zoom Colposcope |
• Urethral Probe |
• Urethral Probe - Long |
• Urological Bougie (FDA Code: FAX / 876.5520) A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower. |
• Urology Surgical Drapes (FDA Code: KKX / 878.4370) |
• Uterine Curettes (FDA Code: HCY / 884.4530) |
• Uterine Manipulator Injector |
• Uterine Manipulator/Injector Cannula (FDA Code: LKF / 884.4530) |
• Uterine Manipulators |
• Uterine Sounds (FDA Code: HHM / 884.4530) |
• Uterine Tenaculum (FDA Code: HDC / 884.4530) |
• Uterine Tenaculum Forceps |
• Uterine Tenaculum Hooks |
• Uterotubal Carbon-Dioxide Insufflator and Accessories (FDA Code: HES / 884.1300) A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas. |
• Vacuum Pump Accessories, Tubing and Filter |
• Vacuum Pump With Bell Cup |
• Vacuum Pump With Mushroom Cup |