Tray
Main information
- Trade name:
- Tray, instrument
- Available from:
- Smith & Nephew Pty Ltd
- Class:
- Class 1
- 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:
- 216660
- Last update:
- 09-10-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
216660
Smith & Nephew Pty Ltd - Tray, instrument
ARTG entry for
Medical Device Included Class 1
Sponsor
Smith & Nephew Pty Ltd
Postal Address
PO Box 393, North Ryde, NSW, 1670
Australia
ARTG Start Date
29/10/2013
Product category
Medical Device Class 1
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
ENTrigue Surgical Inc
12672 Silicon Drive Suite 150
San Antonio, TX, 78249
United States Of America
Products
1. Tray, instrument
Product Type
Single Device Product
Effective date
29/10/2013
GMDN
12143 Tray, instrument
Intended purpose
The tray is used for loading instruments in order to conveniently organize, sterilize, transport, and store the
instruments between uses.
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 04:35:04 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.
Register now for full access
5-11-2018
Home Hardware Stores Ltd. Recalls Benchmark Step Ladder with Tray
The platform on the ladder does not lock securely in place posing a potential fall hazard.
Health Canada
29-8-2018
Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials
Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...
Europe - EFSA - European Food Safety Authority Publications
16-6-2018
Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk
Del Monte Fresh Produce N.A., Inc. ("Del Monte Fresh") announced today, the voluntary recall of a limited quantity of 6 oz., 12 oz. and 28 oz. vegetable trays containing fresh broccoli, cauliflower, celery sticks, carrots, and dill dip sold to select retailers in Illinois, Indiana, Iowa, Michigan, Minnesota and Wisconsin. Del Monte was notified by state agencies of the outbreak and its potential involvement.
FDA - U.S. Food and Drug Administration
16-6-2018
FDA Investigates Multistate Outbreak of Cyclospora illnesses linked to Del Monte Vegetable Trays
The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and state and local officials have been investigating a cluster of cyclosporiasis illnesses associated with recalled Del Monte vegetable trays from Kwik Trip/Kwik Star locations in the United States.
FDA - U.S. Food and Drug Administration
There are no news related to this product.