Device Dossier

Non-implantable needle guide, single-use

Device Dossier for Non-implantable needle guide, single-use (Non-implantable needle guide, single-use, Class IIa, sponsor Emergo). ARTG record, intended…

Intended purpose

The Biopsy Kit is intended to be used with the iSR'obot Mona Lisa. The probe sheath provides a protective cover system for the ultrasound transducer usage in the rectum to prevent microbial and other contamination. The needle guide serves as a guidance for a biopsy needle during the procedure. The kit consists of a needle guide, an ultrasound probe sheath, a plastic drape, and a pouch of biopsy papers.

TGA Public Summary