Device Dossier

Applicator, surgical sealant, dual-channel

Device Dossier for Applicator, surgical sealant, dual-channel (Applicator, surgical sealant, dual-channel, Class IIa, sponsor Device Technologies). ARTG…

Intended purpose

A radiopaque applicator to which a pre-filled syringe of Glubran 2 glue is attached. The radiopaque applicator conveys the glue injected along the external wall of the segment of the sheath between the skin and artery and the radiopacity allows optimal visualisation of the position of the device. It is to be used in haemostatic procedures with Glubran 2 glue during removal of introducers in arterial femoral intravascular percutaneous procedures. It is used to apply surgical glue topically either during surgery or during the treatment of traumatic and atraumatic skin wounds. Surgical application can be either direct, drop by drop or through a laparoscope.

TGA Public Summary