Pure Global

Soft-tissue biopsy needle, single-use

Access comprehensive regulatory information for Soft-tissue biopsy needle, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by BTC Speciality Health Pty Ltd, manufactured by IZI Medical Products LLC in United States of America. The device registration started on April 07, 2020.

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 IIa
Class IIa
Soft-tissue biopsy needle, single-use
Australia TGA ARTG Registered Device
Good Name: BTC Speciality Health Pty Ltd - Soft-tissue biopsy needle, single-use
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Pricing
Intended Purpose

A lightweight needle with a beveled point stylet and an etched tip intended for soft-tissue biopsy. The needle is supplied with or without a coaxial needle which can be placed prior to the needle, allowing access to a target lesion to take multiple samples with only one puncture.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 07, 2020
Effective Date
April 07, 2020
Manufacturer
Country
United States of America
Address
5 Easter Court Suite J, Owings Mills, MD, 21117