Pure Global

Sterile Single Use Instruments - Surgical procedure kit, orthopaedic, single-use, non-medicated

Access comprehensive regulatory information for Sterile Single Use Instruments - Surgical procedure kit, orthopaedic, single-use, non-medicated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Australian Orthopaedic Fixations Pty Ltd, manufactured by Australian Orthopaedic Fixations Pty Ltd in Australia. The device registration started on September 01, 2022.

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
Class IIa
Sterile Single Use Instruments - Surgical procedure kit, orthopaedic, single-use, non-medicated
Australia TGA ARTG Registered Device
Good Name: Australian Orthopaedic Fixations Pty Ltd - Sterile Single Use Instruments - Surgical procedure kit, orthopaedic, single-use, non-medicated
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Intended Purpose

A collection of sterile surgical instruments, including cannula intended to be used to introduce other instruments such as wires and trocars, necessary to perform an orthopaedic surgical procedure. These devices are single use.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
September 01, 2022
Effective Date
September 01, 2022
Manufacturer
Country
Australia
Address
18 Kinkaid Avenue, NORTH PLYMPTON, SA, 5037