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 Ultramed). ARTG record,…
- GMDN category: Non-implantable needle guide, single-use
Intended purpose
Biopsy Needle guide is a disposable product which is attached to a transrectal or transvaginal ultrasound probe to be a guide for inserting needle into target tissue. A sterile device designed to lead a needle into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.