Device Dossier
Disposable Pre-calibrated Biopsy Needle - Biopsy kit, brain
Device Dossier for Disposable Pre-calibrated Biopsy Needle - Biopsy kit, brain (Biopsy kit, brain, Class III, sponsor Brainlab). ARTG record, intended…
- GMDN category: Biopsy kit, brain
Intended purpose
The Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm is an accessory of a compatible Brainlab Cranial Navigation software and hardware for tissue sampling for diagnostic purposes
Functional description
The Disposable Pre-calibrated Biopsy Needle for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue. The device is provided in a set. The Disposable Pre-calibrated Biopsy Needle is a dual cannula device made from stainless steel. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated against the outer cannula to cut the tissue. The device is labelled as MR conditional