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Manufacturers
Integra Neurosciences Pty Ltd
제조사 모회사 (2017)
Integra Neurosciences Pty Ltd
Source
DHTGA
17 Events
Integra CT-compatible Intubation Head Ring Assembly (HRAIM), (used to stabilise the head during an imaging procedure) 의 리콜
CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator 의 리콜
DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Regeneration Matrix (Dura mater grafts indicated for the repair or primary closure of dura (brain and spinal chord) for regeneration) 의 리콜
NeuraGen Nerve Guide (Indicated for the repair of peripheral nerve discontinuities); NeuraWrap Nerve Protector (Indicated to provide nerve protection following peripheral nerve surgery) 의 리콜
PANTA Arthrodesis Nail & PANTA XL Arthrodesis Nail (Intramedullary tibial nail) 의 리콜
Integra Ojemann Cortical Stimulator (Electrical antiseizure brain stimulator) 의 리콜
CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator 의 리콜
HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis) 의 리콜
CUSA Excel+ Sterile Torque Disposable Wrench (23kHz) 의 리콜
LED Single Bay Battery Charger, supplied with LED Headlight System 의 리콜
Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators 의 리콜
Integra Mayfield Ultra 360 Base Unit 의 리콜
Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature MonitorIntegra Camino Intracranial Pressure (ICP) Monitor 의 리콜
ACHILLON Minimally Invasive Achilles Tendon Suture System 의 리콜
Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage) 의 리콜
Hallu-Fix Drill, Diameter 1.9mm, supplied in Hallu-Fix system instrumentation set (used for orthopaedic foot surgery) 의 리콜
Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 17 건
Integra CT-compatible Intubation Head Ring Assembly (HRAIM), (used to stabilise the head during a...
모델명 / 제조번호(시리얼번호)
Integra CT-compatible Intubation Head Ring Assembly (HRAIM), (used to stabilise the head during an imaging procedure) Catalogue Number : HRAIMAll lot numbers ARTG Number: 160533
CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator
모델명 / 제조번호(시리얼번호)
CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic AspiratorCatalogue Numbers: C6623, C6636All lot numbers affectedARTG Number: 197945
DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Rege...
모델명 / 제조번호(시리얼번호)
DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Regeneration Matrix (Dura mater grafts indicated for the repair or primary closure of dura (brain and spinal chord) for regeneration)Catalogue Numbers: ID-1101-(I), ID-1105-(I), ID-1301-(I), ID-1305-(I), ID-2201-(I), ID-2205-I, ID-3305-(I), ID-4501-(I), DP-1013-I, DP-1022-I, DP-1033-I, DP-1045-I, DP-1057-I, DURS2291, DURS3391, DURS4591Multiple lots affectedARTG: 158829, 158825 & 158826
의료기기 분류등급
Neurological Devices
NeuraGen Nerve Guide (Indicated for the repair of peripheral nerve discontinuities); NeuraWrap Ne...
모델명 / 제조번호(시리얼번호)
NeuraGen Nerve Guide (Indicated for the repair of peripheral nerve discontinuities); NeuraWrap Nerve Protector (Indicated to provide nerve protection following peripheral nerve surgery)Catalogue Numbers: PNG130, PNG320, PNG520, PNG620, PNG630, NW320, NW340, NW520, NW540, NW740, NW1040Lot Numbers: 1112378, 1112106, 1112004, 1112030, 1111903, 1111938, 1105268, 1112038, 1111971, 1112104, 1112105, 1112297, 1111853, 1112107ARTG Numbers : 158870 and 158924
의료기기 분류등급
Neurological Devices
PANTA Arthrodesis Nail & PANTA XL Arthrodesis Nail (Intramedullary tibial nail)
모델명 / 제조번호(시리얼번호)
PANTA Arthrodesis Nail & PANTA XL Arthrodesis Nail (Intramedullary tibial nail)Catalogue number: 500-050, 500-080, 500-150, 500-180, 500-250, 500-280, 500-350, 500-380, 510-111, 510-141, 510-211, 510-241, 510-311, 510-341All batch numbers are affected. ARTG Number: 173962
하나 더 12 건 더
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