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…

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

TGA Public Summary