Device Dossier
Irrigation tubing set, general purpose
Device Dossier for Irrigation tubing set, general purpose (Surgical irrigation tubing set, single-use, Class IIa, sponsor Life Healthcare). ARTG record,…
- GMDN category: Surgical irrigation tubing set, single-use
Intended purpose
Tubesets are intended for use in providing irrigation fluid during fragmentation, disection and/or aspiration of both soft and hard (e.g.: bone) tissue in the following surgical specialties: neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecology, and thoracic surgery podiatry. The device is also intended for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.