Sterilizer
Main information
- Trade name:
- Sterilizer, moist heat, wrapped goods
- Available from:
- Device Technologies Australia Pty Ltd
- Class:
- Class IIb
- Medicine domain:
- Humans
- Medicine type:
- Medical device
Documents
- for the general public:
- Public Assessment Report
-
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
Australia
- Language:
- English
Other information
Status
- Source:
- Dept. of Health,Therapeutic Goods Administration - Australia
- Authorization number:
- 217518
- Last update:
- 09-10-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
217518
Device Technologies Australia Pty Ltd - Sterilizer, moist heat, wrapped goods
ARTG entry for
Medical Device Included Class IIb
Sponsor
Device Technologies Australia Pty Ltd
Postal Address
Locked Bag 521,FRENCHS FOREST, NSW, 2086
Australia
ARTG Start Date
20/11/2013
Product category
Medical Device Class IIb
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
Steris Mexico S de R L de C V
Avenida Avante 790 Parque Industrial
Guadalupe
Guadalupe, Nuevo Leon, 67190
Mexico
Products
1. Sterilizer, moist heat, wrapped goods
Product Type
Single Device Product
Effective date
20/11/2013
GMDN
38671 Sterilizer, moist heat, wrapped goods
Intended purpose
A Steam Sterilizer intended for use in healthcare facilities to sterilize wrapped or unwrapped, heat and
moisture stable medical devices using saturated steam.
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 02:03:45 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
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
Documents in other languages are available here
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