Device Dossier
Sterile ultrasound coupling gel
Device Dossier for Sterile ultrasound coupling gel (Sterile ultrasound coupling gel, Class IIa, sponsor Getz Healthcare). ARTG record, intended purpose,…
- GMDN category: Sterile ultrasound coupling gel
Intended purpose
The sterile ultrasound gel is intended to provide a coupling between an ultrasound transducer and the patient to facilitate the passage of ultrasonic waves allowing ultrasound to penetrate into the anatomical area being examined. The characteristic of sterility makes it suitable for use during surgical procedures, biopsies and similar applications where the risk of infection is high and where sterility is required. Recommended for examinations of patients, including pediatric, where, although there is not the presence of damaged skin, or injuries, the risk of infection is still high. This is a sterile single use device.