Summary for ARTG Entry:
Applied Medical Australia Pty Ltd - Abdominal radial retractor
ARTG entry for
Medical Device Included Class IIa
Applied Medical Australia Pty Ltd
PO Box 1545,STAFFORD CITY, QLD, 4053
ARTG Start Date
Medical Device Class IIa
- 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.
Applied Medical Resources
22872 Avenida Empressa
Rancho Santa Margarita, California, 92688
United States Of America
1. Abdominal radial retractor
Single Device Product
47431 Abdominal radial retractor
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.
No Specific Conditions included on Record
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