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Ostene Bone Hemostasis Material - Bone wax, synthetic

Access comprehensive regulatory information for Ostene Bone Hemostasis Material - Bone wax, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Baxter Healthcare Pty Ltd, manufactured by Apatech Limited in United Kingdom. The device registration started on October 16, 2014.

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 III
Class III
Ostene Bone Hemostasis Material - Bone wax, synthetic
Australia TGA ARTG Registered Device
Good Name: Baxter Healthcare Pty Ltd - Ostene Bone Hemostasis Material - Bone wax, synthetic
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Intended Purpose

OSTENE is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 16, 2014
Effective Date
October 16, 2014
Manufacturer
Country
United Kingdom
Address
360 Centennial Avenue Centennial Park, Elstree, Hertfordshire, WD6 3TJ