Summary for ARTG Entry:
Karl Storz Endoscopy Australia Pty Ltd - Tissue reconstructive material, synthetic, silicone, block
ARTG entry for
Medical Device Included Class 1
Karl Storz Endoscopy Australia Pty Ltd
PO Box 50,LANE COVE, NSW, 1595
ARTG Start Date
Medical Device Class 1
- 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.
Karl Storz GmbH & Co KG
TUTTLINGEN, Tuttlingen, D 78532
1. Tissue reconstructive material, synthetic, silicone, block
Single Device Product
45230 Tissue reconstructive material, synthetic, silicone, block
A block of silicone elastomer typically modified and implanted for tissue reconstruction during a surgical
procedure. The device may or may not be sterile or reinforced (e.g., with polyester textile). It may be cut
into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that
include repair of nasal septums, perforated eardrums, herniations, diaphragms, orbital floors, or congenital
fissures of the abdominal wall.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:45:24 AEDT
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