Summary for ARTG Entry:
Medi Dent Disposable International - Surgical procedure kit, general-purpose, single-use, non-medicated
ARTG entry for
Medical Device Included Class IIa
Medi Dent Disposable International
PO Box 8160,MAROOCHYDORE, QLD, 4558
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.
Nanjing Sealand Medical Co Ltd
No 13 Shen Yuan Road
Li Shui Development Zone, Nanjing, 211200
1. Surgical procedure kit, general-purpose, single-use, non-medicated
33961 Surgical procedure kit, general-purpose, single-use, non-medicated
The device consists of a collection of disposable, single use, hand held, non-active surgical instruments,
dressing materials and components presented in a sterile pack. The device is intended to be used by
health professionals to perform general purpose surgical procedures. Some of the surgical instruments
included in the device are invasive devices intended for transient use in the oral cavity and do not contain
any pharmaceuticals. All the components in the sterile pack are class IIa or class I medical devices.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:40:09 AEDT
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