Pure Global

Dispenser, cement, orthopaedic

Access comprehensive regulatory information for Dispenser, cement, orthopaedic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by BTC Speciality Health Pty Ltd, manufactured by IZI Medical Products LLC in United States of America. The device registration started on August 23, 2019.

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 Is
Class Is
Dispenser, cement, orthopaedic
Australia TGA ARTG Registered Device
Good Name: BTC Speciality Health Pty Ltd - Dispenser, cement, orthopaedic
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Intended Purpose

Designed for placing bone cement into surgical sites and intended for use by physicians trained and experienced in bone access and infusion techniques.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 23, 2019
Effective Date
August 23, 2019
Manufacturer
Country
United States of America
Address
5 Easter Court Suite J, Owings Mills, MD, 21117