Zeta Stylet — S

Primary DI

00860012056804

Brand

Zeta Stylet — S

Company

Zeta Surgical Inc.

Model

ZSS-110 US

Device description

The Zeta Stylet is a guiding stylet to be used in conjunction with the Zeta Navigation System for navigated placement of catheters, shunts or similar devices during cranial procedures. The instrument is single-use and not intended for reprocessing or reuse. The stylet is designed with mounting posts to attach the NDI passive marker spheres (K033621) for stereotaxic navigation. These mounting posts are pre-assembled on the Stylet handle during assembly. The Stylet with attached mounting posts is provided clean and non-sterile to the clients (e.g., hospitals). The clients are required to sterilize the Stylet according to the provided Instructions for Use (IFU) and store according before the procedure. The NDI passive marker spheres are provided sterile. The users are trained on installing the NDI passive marker spheres before the procedure. The Zeta Stylet is compatible with catheters with inner diameter from 1.5 mm to 1.9 mm. Both the handle and the rod of the Stylet are made of Titanium (grade 23). The mounting post is made of medical-grade stainless steel. The mounting posts and NDI passive marker spheres are supplied off-the-shelf by NDI (Canada).

Published

2026-05-26

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

OTC

false

Sterile

false

Single use

true