ISO 13485 Certified - CE Mark - FDA Registered

INTRODUCTION

Introduction

Trewavis Surgical is a specialist manufacturer of reusable and single use sterile electrosurgical instruments and accessories, Kirschner Wires, Steinmann Pins, Retractors and a unique Rectal Biposy Tool (SBT 100) used in paediatrics. Trewavis Surgical is an international supplier of these products.

Reusable and single use electrosurgical instruments and accessories

The Company manufactures a full range of bipolar and monopolar forceps, electrodes (general, arthroscopy, Lletz/LEEP, and specialty), laparoscopy probes/electrodes, electrode holders and leads.
Non-Stick electrodes are also available.
Cleaning and sterilisation instructions are enclosed with the devices.
The reusable and single use electrosurgical instruments and accessories are compatible with most electrosurgical generators and systems currently being used throughout the world.
Trewavis Surgical can manufacture electrosurgical devices to your specifications. Custom made products are non-returnable.

Kirschner Wires and Steinmann Pins

A full range of non-sterile bone wires and pins are manufactured, in implant grade stainless steel, to the highest international standards.

Rectal Suction Biopsy Tool (SBT 100)

This unique instrument has been designed to collect biopsy specimens to aid in the diagnosis of Hirschsprung's Disease in new-born and young children. It has been sold throughout the world for over 20 years.

Instrument Repairs

Trewavis Surgical offers a fast, reliable and cost effective instrument repair and maintenance service. The company specialises in the reinsulation of electrosurgical devices using the highest quality insulation materials available.

Quality Assurance

Trewavis Surgical is ISO13485 certified, FDA GMP compliant and is an FDA registered manufacturer. The company holds TGA conformity assesment certificate No. AU Q00041/01 Trewavis Surgical's products conform to the requirements of the European Union's Directive 93/42/EEC on Medical Devices and holds certificate No. MRA Q00021/01. The company's Authorised Representative in the EU is: Trewavis Surgical Instruments Pty Ltd 31 Harley Street London W1G 9QS United Kingdom Trewavis Surgical offers an unsurpassed level of service and quality.

Warranty

All products of Trewavis Surgical are shipped free of defects in materials and workmanship. Trewavis Surgical will repair or replace, at its option, products which have been returned to it or its distributor within 30 days after shipment of the product to the original Purchaser, and which on examination discloses, to the Company's satisfaction, that the product is defective and was not the subject of misuse or modification from original specifications. A full Warranty Statement is included with the Instructions for Use packed with each product.

Distribution

Please contact Trewavis Surgical for details of your nearest distributor.