Device Dossier
Non-vascular guidewire
Device Dossier for Non-vascular guidewire (Non-vascular guidewire, Class IIa, sponsor Smiths Medical). ARTG record, intended purpose, GMDN category —…
- GMDN category: Non-vascular guidewire
Intended purpose
The device is a metal wire to be used to position a tracheostomy tube pre-dilator catheter, and subsequently a tracheostomy tube, within a patient's trachea. The guidewire is to be moved into the desired position, which then facilitates the introduction and correct placement of the pre-dilation catheter and tracheostomy tube. The guidewire is intended for transient use.