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AgX100® I125 Implants: Loose Seeds and Cartridge loaded - Radionuclide source, therapeutic, brachytherapy, manual, permanent implant - ARTG 472645

Access comprehensive regulatory information for AgX100® I125 Implants: Loose Seeds and Cartridge loaded - Radionuclide source, therapeutic, brachytherapy, manual, permanent implant in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 472645 and sponsored by RQSolutions Medical Devices Distribution Support, manufactured by Theragenics Corporation in United States of America. The device registration started on December 11, 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 III
ARTG 472645
Class III
AgX100® I125 Implants: Loose Seeds and Cartridge loaded - Radionuclide source, therapeutic, brachytherapy, manual, permanent implant
ARTG ID: 472645
Good Name: RQSolutions Medical Devices Distribution Support - AgX100® I125 Implants: Loose Seeds and Cartridge loaded - Radionuclide source, therapeutic, brachytherapy, manual, permanent implant
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Intended Purpose

AgX100® seeds are indicated for the permanent interstitial treatment of localized prostate cancer. The seeds may be used as a primary monotherapy (single treatment) or in combination with other treatment modalities such as external beam radiation therapy and/or androgen deprivation therapy.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
472645
Start Date
December 11, 2024
Effective Date
December 11, 2024
Manufacturer
Country
United States of America
Address
5203 Bristol Industrial Way, Buford, GA, 30518