Gyrus ACMI

Address: 136 Turnpike Road, Southborough, Massachusetts 01772-2104, USA
Phone: +1-(508)-804.2600 | Fax: +1-(508)-804.2624 | Map/Directions >>

Profile: Gyrus ACMI is engaged in medical device business. We offer urology, gynecology, ENT and anesthesiology products. Our urology products include cystourethroscopes, cystonephroscopes, laparoscopy, percutaneous nephroscopes and urodynamics.

The company was founded in 1900, has revenues of USD 50-100 Million, has ~100 employees and is ISO 9000, ISO 9001, ISO 9002, CE certified.

FDA Registration Number: 1519132

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• Standard Resection Electrodes
• Sterile Obturators
• Sterilization Wrap Containers (FDA Code: KCT / 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.
• Stone Extractors
• Stone Grasping Forceps
• Stone Manipulation, Stone Extractors
• Strabismus Muscle Forceps
• Straight Dressing Forceps
• Straight Iris Forceps
• Straight Suturing Forceps
• Straight Tissue Forceps
• Straight Uterine Curette w/Regular Tip
• Suction Irrigation Probes
• Suction Irrigation Systems
• Suprapubic Catheter and Accessories (FDA Code: KOB / 876.5090)
A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.
• Suprapubic Urodynamics Catheter Set
• Surgical Bone Holding forceps
• Surgical Camera and Accessories (FDA Code: KQM / 878.4160)
A surgical camera and accessories is a device intended to be used to record operative procedures.
• Surgical forceps
• Surgical Hooks
• Surgical Instruments, Bone Hooks
• Surgical prostate Cryoablation System
• Surgical Retractor (FDA Code: GAD / 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 Retractor Systems (FDA Code: GAD / 878.4800)
• Surgical Tissue Forceps
• Suture tying Forceps
• Swiss Cilia Forceps
• Temporary Prostatic Stent
• Thin capsulorhexis Forceps
• Thoracic Curettes
• Thoracic Ring Curettes
• Thumb Dressing Forceps
• Tipless Stone Extractors
• Tissue Removal Systems
• Titanium Bayonet Forceps
• Titanium Bipolar Forceps (Ophthalmology)
• Titanium Monolithic Implant Systems
• Titanium RETINAL Forceps
• Titanium vitreoretinal Intraocular Forceps
• Tracheal Tube Cleaning Brushes (FDA Code: EPE / 868.5795)
A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients.
• Tracheal Tube Stylet (FDA Code: BSR / 868.5790)
A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
• Tracheal Tube with/without Connector (FDA Code: BTR / 868.5730)
A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
• Twisted Disposable Subdermal Needle Electrodes
• Ultrasonic Lithotripsy System
• Ultrasonic Lithotriptor (FDA Code: FEO / 876.4480)
• Ureteral Catheter
• Ureteral Guidewires
• Ureteroscopic Biopsy Forceps
• Urethral Diversion Stents
• Urethral Trays

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