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Suture/needle passer, single-use

Access comprehensive regulatory information for Suture/needle passer, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by GRC Surgical Pty Ltd, manufactured by Fannin UK Ltd in United Kingdom. The device registration started on June 16, 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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TGA ARTG Official Data
Class IIa
Class IIa
Suture/needle passer, single-use
Australia TGA ARTG Registered Device
Good Name: GRC Surgical Pty Ltd - Suture/needle passer, single-use
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Intended Purpose

The Espiner SuitORpass ensures consistent, effective placement of sutures during and at the completion of a range of laparoscopic procedures. It facilitates closures of the small and large port sites and secures prosthetic materials for laparoscopic incision in patients typically weighing more than 10kg. Designed as a rigid needle, the SuitORpass enables fast and controlled penetration of subcutaneous tissue, including fascia and peritoneum.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 16, 2023
Effective Date
June 16, 2023
Manufacturer
Country
United Kingdom
Address
Yeo Bank 3 Kenn Road, Clevedon, Somerset, BS21 6TH