Australia TGA ARTG record

Suture/needle passer, single-use

Australia TGA ARTG Registered Device · Pureplay Orthopaedics · Parcus Medical LLC · Class IIa · Started May 13, 2021

Good Name: Pureplay Orthopaedics - Suture/needle passer, single-use

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 13, 2021
Effective Date: May 13, 2021

Sponsor

Name: Pureplay Orthopaedics

Manufacturer

Name: Parcus Medical LLC
Country: United States of America
Address: 6423 Parkland Drive, Sarasota, FL, 34243

Intended purpose

The Parcus PTS suture passing needle is designed to affect placement of a suture through soft tissue

About this record

Access comprehensive regulatory information for Suture/needle passer, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Pureplay Orthopaedics, manufactured by Parcus Medical LLC in United States of America. The device registration started on May 13, 2021.

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.