7fce0a78-440d-4f9c-ab47-5581ea2b5e1aUpdatePublished52024-09-022015-10-24In Commercial Distribution00821925006263PrimaryGS1TECOFLEX5617030007198742Gyrus ACMI, LLC17.0FR(2.3mm) X 30 cm DOUBLE PIGTAIL URETERAL STENT TECOFLEX falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse18885247266xxx@xxx.xxxK96014800058005Polymeric ureteral stentA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.trueActiveFADStent, Ureteraltruefalse