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Hard-tissue ultrasonic surgical system handpiece tip

Access comprehensive regulatory information for Hard-tissue ultrasonic surgical system handpiece tip in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Integra Neurosciences Pty Ltd, manufactured by Integra LifeSciences (Ireland) Ltd in Ireland. The device registration started on April 08, 2024.

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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Class I
Class I
Hard-tissue ultrasonic surgical system handpiece tip
Australia TGA ARTG Registered Device
Good Name: Integra Neurosciences Pty Ltd - Hard-tissue ultrasonic surgical system handpiece tip
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Intended Purpose

Sterile, single use tip pack; to be attached to handpiece intended for use with ultrasonic surgical aspirator systems which are indicated for surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable. This includes neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopaedic surgery, gynaecological surgery and laparoscopic surgery. The tip is intended for use with bone only.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
Start Date
April 08, 2024
Effective Date
April 08, 2024
Manufacturer
Country
Ireland
Address
IDA Business and Technology Park Sragh, Tullamore, County Offaly