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Manufacturers
Pyramed Pty Ltd
Manufacturer Parent Company (2017)
Device Technologies Australia Pty. Ltd.
Source
DHTGA
6 Events
Recall of Balt Cristal Balloons
Recall of Venture RX, OTW and CS Catheters
Recall of Twin-Pass dual access catheters
Recall of Sinus-SuperFlex-635 Self-expanding Nitinol Stent System
Recall of Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm
Recall of GUIDELINER Intravascular Guiding Catheter
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6 devices in the database
Balt Cristal Balloons
Model / Serial
Balt Cristal BalloonsProduct Number: CBV18x40/110Batch Number: 00294780 - Expiry Date: 30/09/2022ARTG Number: 164958
Venture RX, OTW and CS Catheters
Model / Serial
Venture RX, OTW and CS CathetersVenture RX Model Number: 5820Venture OTW Model Number: 5821Venture CS Model Number: 5882 Multiple Lot NumbersSupplied under Special Access Scheme (SAS)
Product Classification
Cardiovascular Devices
Twin-Pass dual access catheters
Model / Serial
Twin-Pass dual access cathetersModel Number: 5200Multiple lot numbers affectedSupplied through the Special Access Scheme (SAS)
Sinus-SuperFlex-635 Self-expanding Nitinol Stent System
Model / Serial
Sinus-SuperFlex-635 Self-expanding Nitinol Stent SystemModel numbers: 8606-6200 and 8607-6200Lot Numbers: Q009591, Q009592, Q008259, Q010150 and Q015955ARTG Number: 178915
Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm
Model / Serial
Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm Model number: BS1003FWLot number: 13D1394D3EB780 Expiry date: 2016-04ARTG number: 130531
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Pyramed Pty Ltd
Manufacturer Parent Company (2017)
Device Technologies Australia Pty. Ltd.
Source
RLMPH
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