Abdominal

Main information

  • Trade name:
  • Abdominal radial retractor
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Abdominal radial retractor
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220280
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220280

Applied Medical Australia Pty Ltd - Abdominal radial retractor

ARTG entry for

Medical Device Included Class IIa

Sponsor

Applied Medical Australia Pty Ltd

Postal Address

PO Box 1545,STAFFORD CITY, QLD, 4053

Australia

ARTG Start Date

20/02/2014

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Applied Medical Resources

22872 Avenida Empressa

Rancho Santa Margarita, California, 92688

United States Of America

Products

1. Abdominal radial retractor

Product Type

Single Device Product

Effective date

20/02/2014

GMDN

47431 Abdominal radial retractor

Intended purpose

The Alexis/Alexis O Wound Protector/Retractor are devices that allows the surgeon to access the

abdominal cavity through an atraumatically retracted wound, providing maximum exposure with minimum

incision size. In addition to incision retraction, it is intended to protect against wound contamination during

both laparoscopic and open surgery. The small and medium Alexis O/Alexis wound protectors/retractors

are capable of temporarily closing an incision to maintain pneumoperitoneum during laparoscopic surgery,

or to serve as an additional trocar port site. In addition, indicated sizes may be used to access the thoracic

cavity or other soft tissue retraction during cardiac and general surgical procedures.

The Alexis O c-section retractor is a device that allows the surgeon to access the abdominal cavity through

an atraumatically retracted abdominal incision, providing maximum exposure with minimum incision size.

The Alexis O c-section retractor (large and extra large) is indicated for use to assist in non-urgent

cesarean deliveries that are routine procedures. It is intended to provide incision retraction and to protect

against wound contamination during a cesarean section.

The Alexis orthopaedic protector is indicated for use to access the musculoskeletal system through an

atraumatically retracted wound.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 04:40:26 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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