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

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• Laser Accessories

• Laser Smoke Evacuation System

• Lateral Vaginal Retractor

• Lateral Wall Retractor

• LEEP Depth Ruler

• LEEP Endocervical Specula

• LEEP Forceps

• LEEP Instruments

• LEEP Iris Hook

• LEEP Retractors

• LEEP Ring Forceps

• LEEP Single Tooth Tenaculum

• LEEP Specula

• LEEP Straight Handled Hook

• LEEP Tenacula and Hooks

• LEEP Three-Prong Hook

• LEEP Tissue Forceps

• LEEP Two-Prong Hook

• LEEP Width Ruler

• Leisegang Standard Colposcope

• Ligature Carrier (FDA Code: GEJ / 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.

• Ligature Carrier Set (FDA Code: GEJ / 878.4800)

• Liquid Nitrogen Container

• 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.

• Mechanical Pumps Vacuum

• Medium Lateral Wall Retractor

• Metal Vaginal Speculum (FDA Code: HDF / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• Microsurgical Television Camera without Audio (FDA Code: FWD / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures.

• Mini-Laparotomy Filshie Clip Applicator

• Multilevel PAP (Positive Airway Pressure) Systems

• Needle Holder/Knot Tying Instrument

• Neonatal Endotracheal Tube Grip

• Neonatal Incubators (FDA Code: FMZ / 880.5400) A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

• Neonatal Infant Warmers

• Neonatal Respiratory Products

• Neonatal Tracheostomy Tubes

• Non Dental Irrigating Syringe (FDA Code: KYZ / 880.6960) An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

• Non-Continuous Ventilator/Respirator (FDA Code: BZD / 868.5905) A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

• Non-Metal Vaginal Speculum (FDA Code: HIB / 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:

• Open-Sided Specula

• Ophthalmic Cryosurgery System

• Otolaryngology Probes

• Overhead Zoom Colposcope

• Paracervical Anesthesia Set (FDA Code: HEE / 884.5100) An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.

• Pelvic Reconstructive Surgery Set

• Percutaneous Biopsy Device (FDA Code: MJG / 878.4800)

• Physical Abuse Colposcope

• Positive Airway Pressure Therapy (CPAP) Systems

• Powered Surgical Laser Instrument (FDA Code: GEX / 878.4810) (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.

• 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.