Device Dossier
Endotherapy guidewire, single-use
Device Dossier for Endotherapy guidewire, single-use (Endotherapy guidewire, single-use, Class IIa, sponsor PlainSolution). ARTG record, intended…
- GMDN category: Endotherapy guidewire, single-use
Intended purpose
It is an endotherapy device used in combination with a compatible flexible endoscope to assist in the insertion of an endoscope or endotherapy devices, during diagnostic and therapeutic endoscopy. It is typically used within the gastrointestinal (GI) tract and is made of a flexible metal coil or wire coated with a plastic material. It has radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.