Surgical power tool system handpiece, rotary, non-rechargeable battery-powered, single-use - ARTG 473716
Access comprehensive regulatory information for Surgical power tool system handpiece, rotary, non-rechargeable battery-powered, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 473716 and sponsored by Lyka Smith Pty Ltd, manufactured by Jeil Medical Corporation in South Korea. The device registration started on December 18, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The SMARTO is intended for use in driving screws, and drilling in conjunction with craniofacial (does not include oromaxillofacial applications), craniotomnies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and single use only.