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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• Pediatric Double Pigtail Stent Sets
• Pediatric Double Pigtail Stent Sets, Multi-Length
• Pediatric Latex Free Sterile Catheter Straight Tip
• Pediatric Resectoscopes
• Pediatric Soft-Tissue Graft
• Pediatric Suprapubic Catheter Sets
• Pediatric Urodynamics Catheters
• Pediatric Variable Length Urethral Stents
• Percutaneous Nephroscopes
• Percutaneous Nephroscopy PCNL, Percutaneous Stone Extractors
• Percutaneous Prostate Cryoablation
• plastic Forceps
• Pneumatic Lithotripsy Systems
• Pneumoperitoneum Needle (FDA Code: FHO / 876.1500)
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
• Polyp Snare
• Polyp SnareT System for Nasal Polyps
• Probe Bayonet Forceps
• 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.
• Punch Forceps
• Renal Extracorporeal Lithotripsy Systems
• Renal Surgical Devices Percutaneous Stone Extractors
• Resection Electrodes
• Resectoscope Working Element (FDA Code: FDC / 876.1500)
• Resectoscopes (FDA Code: FJL / 876.1500)
• Reusable Biopsy Forceps
• Reusable Bipolar Forceps
• Reusable Concentric Needle Electrodes
• Reusable Monopolar Needle Electrodes
• Reusable Obturators
• Reusable Single Fiber Needle Electrode
• Rigid Cystoscopes
• Rigid Laryngoscope (FDA Code: CCW / 868.5540)
A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
• Ring Forceps
• Rotating Continuous Flow Resectoscopes
• Rotating Resectoscopes
• Rustproof Intraocular Forceps
• Self Centering Bone Holding Forceps
• Semi Rigid biopsy forceps
• Semi Rigid Fiberoptic Ureteroscopes
• Semi-Rigid Ureteroscopes
• Semi-Rigid Ureterscopes
• Serrated Jaw Intraocular Forceps
• Sharpening Kit for Reusable Needle Electrodes
• Sheaths and Obturators for Hysteroscopic Procedures
• Shockwave Lithotripsy Systems
• Small-diameter Semirigid Ureteroscopes
• Special Purpose Electrosurgical Equipment
• Stainless Steel Cilia Forceps
• Stainless Steel Watchmaker Forceps
• Standard Flow Resectoscopes

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