Sphincterotome AG-50910-0525-W2545

The Sphincterotome AG-50910-0525-W2545 is an electrosurgical endoscopic device designed specifically for transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. This procedure creates a controlled incision in the sphincter tissue to facilitate cannulation of the biliary ducts, enabling access for diagnostic or therapeutic interventions such as ERCP (Endoscopic Retrograde Cholangiopancreatography).

The Sphincterotome AG-50910-0525-W2545 is supplied sterile in sealed containers, ensuring readiness for immediate use without additional preparation. It is intended for single-use only and must not be reused, as reuse could compromise sterility and device integrity. The packaging includes unique UDI-DI codes (06959664934067, 16959664934064, 26959664934061) for traceability.

No, the Sphincterotome AG-50910-0525-W2545 is non-latex and contains no animal or human tissue components. This design reduces the risk of allergic reactions or contamination concerns, making it suitable for patients with latex sensitivities or other restrictions.

The device holds FDA 510(k) clearance (K201121) and is compliant with the EU Medical Device Regulation (MDR). It is classified under Class IIb and adheres to strict regulatory standards for endoscopic electrosurgical instruments. The UDI (695966495091000016F) ensures traceability throughout its lifecycle.

The Sphincterotome should be stored in its original sterile packaging in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Avoid exposure to moisture or contaminants, as this could compromise sterility. Once opened, the device must be used immediately and discarded per single-use guidelines.