755809f3-d634-474d-b7b5-a3da574b6b6fUpdatePublished22026-03-102023-06-132025-05-19Not in Commercial Distribution00860222000406PrimaryGS1DV8® Retractor1407515014075150117502037Manual Surgical Sciences, L. L. C.1The DV8® Retractor Esophageal Balloon (DV8 Retractor) is a non-sterile, single-use, disposable esophageal balloon retractor. The DV8 Retractor is deployed orally and inflated inside the esophagus. The retractor gently and effectively retracts the esophagus to create a stable operating field. falsetruefalsefalsefalsetruetruefalsetruetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse62204Intraluminal oesophageal retractorA hand-held manual instrument intended to be orally introduced into the oesophagus during thoracic surgery to mechanically divert the oesophagus away from the site of surgery, to facilitate surgical site access and to help prevent injury. It is available in a variety of forms (e.g., curved metal wire, metal rod with balloon). This is a single-use device.falseActiveGADRetractorBalloon DiameterBalloon Lengthfalsefalse