Profile: Smart Medical Systems Ltd. develops medical devices for gastroenterology, endoscopy and related applications. Our NaviAid™ is a family of disposable add-on balloon device, designed for a variety of applications. Our NaviAid™ BGE device, comprising a disposable element mounted on the standard endoscope tip and a supporting air supply unit, advances the standard endoscope deep into the small intestine while utilizing the existing endoscope optics, utilities and accessory channel. Our NaviAid™ BGE advantages are small bowel endoscopy with standard GI endoscopes, that enables advanced small bowel diagnosis. The NaviAid™ ASU is a simple console, which provides air inflation and deflation for various disposable balloon products.
The company is ISO 13485:2003 certified.
FDA Registration Number: 3005261802
US Agent: N/a / N/a
3 Products/Services (Click for related suppliers)
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| • Endoscope Accessories (FDA Code: KOG) |
| • Endoscopy & Endoscopes |
| • Enteroscope and Accessories (FDA Code: FDA / 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. |