Pure Global

Skin microbial sealant

Access comprehensive regulatory information for Skin microbial sealant in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Surgical Specialties Pty Ltd, manufactured by Advanced Medical Solutions Limited in United Kingdom. The device registration started on March 24, 2023.

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 Is
Class Is
Skin microbial sealant
Australia TGA ARTG Registered Device
Good Name: Surgical Specialties Pty Ltd - Skin microbial sealant
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Intended Purpose

INTEGUSEAL Microbial Sealant is a film forming; cyanoacrylate based microbial sealant provided in a ready to use applicator. INTEGUSEAL Microbial Sealant is intended for use after typical preoperative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of skin flora contamination throughout a surgical procedure.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 24, 2023
Effective Date
March 24, 2023
Manufacturer
Country
United Kingdom
Address
Western Wood Way Langage Science Park, Plymouth, Devon, PL7 5BG