Device Dossier
Disposable Biopsy Needle Kit - Biopsy kit, brain
Device Dossier for Disposable Biopsy Needle Kit - Biopsy kit, brain (Biopsy kit, brain, Class III, sponsor Brainlab). ARTG record, intended purpose, GMDN…
- GMDN category: Biopsy kit, brain
Intended purpose
Extraction of brain-tissue for diagnostic purposes.
Functional description
The device is indicated for extraction of brain-tissue for diagnostic purposes. The kit consists of a 2-parted cannula (outer cannula and inner cannula with cutting specimen chamber), syringe with stopcock valve and ruler (to adjust the depth stop). The 2-parted cannula is inserted into the guiding cylinder of a stereotaxy apparatus and directed to the trepanation area. The syringe is used to create a vacuum to draw tissue into the biopsy duct. By rotation of the inner cannula the tissue is cut.