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Medical equipment drape, single-use

Access comprehensive regulatory information for Medical equipment drape, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Optimized Ortho Pty Ltd, manufactured by Whitney Medical Solutions in United States of America. The device registration started on August 12, 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.

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Class Is
Class Is
Medical equipment drape, single-use
Australia TGA ARTG Registered Device
Good Name: Optimized Ortho Pty Ltd - Medical equipment drape, single-use
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Intended Purpose

A device used to provide a sterile barrier between otherwise non-sterile handheld devices (such as tablets, mobile phones, and cameras, etc.) and the sterile field, including the scrubbed and gloved hands of medical professionals to allow manipulation of the device without compromising sterility of the field. It is a sterile, single-use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 12, 2022
Effective Date
August 12, 2022
Manufacturer
Country
United States of America
Address
5737 W Howard St, Niles, Illinois, 60714