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A sterile solution intended to be injected via an endoscopic injection needle into the submucosal layer of the gastrointestinal tract to facilitate excision of mucosal lesions (e.g. polyps, adenomas, early cancers) by lifting the mucosa over a bubble of fluid. it is typically a gel-like substance containing an emulsion of fats and salts, and may include a dye. This is a single-use device.
Details
Device typeSubmucosal lift solution: A sterile solution intended to be injected via an endoscopic injection needle into the submucosal layer of the gastrointestinal tract to facilitate excision of mucosal lesions (e.g., polyps, adenomas, early cancers) by lifting the mucosa over a bubble of fluid. It is typically a gel-like emulsion (e.g., containing fats and/or salts), and may include a dye. This is a single-use device.
FDA categorySubmucosal Injection Agent
Device ID05391530190015
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information