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Manufacturers
Ellex Medical Pty Ltd
Manufacturer Parent Company (2017)
Ellex Medical Lasers Ltd.
Source
DHTGA
2 Events
Recall of Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe Kit
Recall of Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System (2RT)
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2 devices in the database
Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe Kit
Model / Serial
Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe KitEllex 14.9mm OD - Prager Adult - Prager scleral shell for BiometryModel No: P-106, PRAGERADULTLot No: AA003725, 15-385, 15-393 and 16-207Ellex 12.5mm OD - Prager Child - Prager scleral shell for BiometryModel No: P-106SV, PRAGERCHILDLot No: 15-32610 MHZ Biometric A Scan Probe Kit (includes Prager Adult)Model No: 10MHZASCAN-KITLot No: 15M028, 15L049, 15M046, 15M057 and 16K050ARTG Number: 242235
Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System ...
Model / Serial
Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System (2RT) Model Numbers: LP5532 and LR1532Multiple Serial Numbers affectedARTG Number: 106758 and 224484
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Ellex Medical Pty Ltd
Manufacturer Address
Ellex Medical Pty Ltd, 82 Gilbert Street, Adelaide Australia
Manufacturer Parent Company (2017)
Ellex Medical Lasers Ltd.
Source
USFDA
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