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 GE Healthcare). ARTG record,…
- GMDN category: Non-implantable needle guide, single-use
- Sponsor: GE Healthcare
Intended purpose
This device is a sterile needle guide intended to be used for mammography for the guidance of the needle for breast biopsies. The device is sterile and intended for single use. This device is designed to lead a needle into its proper course when performing a clinical and/or surgical procedure.