Instrument equipment
Main information
- Trade name:
- Instrument/equipment drape, single-use
- Available from:
- Surgicore Pty Ltd
- Class:
- Class Is
- 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:
- 221821
- Last update:
- 08-10-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
221821
Surgicore Pty Ltd - Instrument/equipment drape, single-use
ARTG entry for
Medical Device Included Class Is
Sponsor
Surgicore Pty Ltd
Postal Address
35 / 45-51 Huntley Street,ALEXANDRIA, NSW, 2015
Australia
ARTG Start Date
31/03/2014
Product category
Medical Device Class Is
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
Novadaq Technologies Inc
13155 Delf Place Unit 250
Richmond, British Columbia, V6V 2A2
Canada
Products
1. Instrument/equipment drape, single-use
Product Type
Single Device Product
Effective date
31/03/2014
GMDN
45021 Instrument/equipment drape, single-use
Intended purpose
A custom sterile surgical drape that attaches via a specially designed optical window and sterile tapes, and
is designed to maintain sterility of the device's articulating arm throughout the procedure.
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 09.11.2017 at 11:42:29 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
- Access to this document is only available to registered users.
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