Pure Global

Suture/needle passer, single-use - ARTG 365893

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 registered under ARTG number 365893 and 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.

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TGA ARTG Official Data
Class IIa
ARTG 365893
Class IIa
Suture/needle passer, single-use
ARTG ID: 365893
Good Name: Pureplay Orthopaedics - Suture/needle passer, single-use
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Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
365893
Start Date
May 13, 2021
Effective Date
May 13, 2021
Manufacturer
Country
United States of America
Address
6423 Parkland Drive, Sarasota, FL, 34243