Pure Global

Applicator, surgical sealant, dual-channel

Access comprehensive regulatory information for Applicator, surgical sealant, dual-channel in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Cryolife Medical (Australia) Company Pty Ltd, manufactured by Artivion Inc in United States of America. The device registration started on April 12, 2007.

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
Applicator, surgical sealant, dual-channel
Australia TGA ARTG Registered Device
Good Name: Cryolife Medical (Australia) Company Pty Ltd - Applicator, surgical sealant, dual-channel
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Intended Purpose

A dual channel device that enables a surgeon to apply with precision a two-component surgical adhesive to a surgical site. Applicator tips are intended to be used only with the prefilled BioGlue Surgical Adhesive (BioGlue) cartridge/syringe(s) - They allow for the proper mixing of the BioGlue implant material.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 12, 2007
Effective Date
April 12, 2007
Manufacturer
Country
United States of America
Address
1655 Roberts Boulevard NW, Kennesaw, Georgia, 30144