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Dura mater sealant - ARTG 406194

Access comprehensive regulatory information for Dura mater sealant in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 406194 and sponsored by Integra Neurosciences Pty Ltd, manufactured by Integra Lifesciences Corporation in United States of America. The device registration started on March 15, 2023.

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 I
ARTG 406194
Class I
Dura mater sealant
ARTG ID: 406194
Good Name: Integra Neurosciences Pty Ltd - Dura mater sealant
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Intended Purpose

The DuraSeal Exact Spine Sealant System is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General-Export
Registration Information
ARTG ID
406194
Start Date
March 15, 2023
Effective Date
March 15, 2023
Manufacturer
Country
United States of America
Address
1100 Campus Road, Princeton, New Jersey, 08540