Pure Global

Cranial port/reservoir

Access comprehensive regulatory information for Cranial port/reservoir 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 Production Corporation in United States of America. The device registration started on May 24, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Cranial port/reservoir
Australia TGA ARTG Registered Device
Good Name: Integra Neurosciences Pty Ltd - Cranial port/reservoir
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

To provide direct access to the lateral cerebral ventricles for aspiration and the injection of medication, and to cystic tumors for chronic drainage or the injection of chemotherapeutic agents and/or radioisotopes via a syringe fitted with a 25-gauge, or smaller, HUBER-point needle through the reservoir dome.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
Start Date
May 24, 2022
Effective Date
May 24, 2022
Manufacturer
Country
United States of America
Address
11 Cabot Blvd, Mansfield, MA, 02048