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 Actis Medical). ARTG record,…

Intended purpose

A rigid, non-powered device designed to direct a sharp needle into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device. This device provides a mechanical means for performing needle / instrument guided procedures with the use of the diagnostic ultrasound endocavity transducer, EV29L.

TGA Public Summary