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Devices
Device Recall LICOX Brain Oxygen Monitoring System
모델명 / 제조번호(시리얼번호)
CC1 Licox¿ PO2 Microprobe, 200 mm 021213, 040414, 070314, 130114, 240214, 270114, 280314, 300614 CC12 Licox¿ PO2 Microprobe, 300 mm 020614, 040814, 050514, 070414, 070714, 220414 CC1.P1 Licox¿ PMO Combined Probe Containing Oxygen and Temperature 050614, 060214, 060314, 100414, 100714, 130214, 130314, 170114, 190614, 210814, 260614, 310714 IM3ST Licox¿ Complete Brain IMC-Probe Kit: 020614, 030314, 110714, 130114, 140314, 160614, 180714, 200114, 280314 IP1.P Licox¿ Single Lumen Bolt CMPS and Temperature Bolt Kit 030714, 060214, 060314, 070814, 080514, 100714, 120614, 130314, 190614, 310714 IP2.P Licox¿ Double Lumen Bolt CMPS, Temperature and ICP Monitoring Kit 030714, 050614, 060214, 060314, 070814, 080514, 090114, 100714, 130314, 140814, 200214, 200414, 260614, 290814 IT2 Licox¿ Tunneling CMPS and Temperature Monitoring Kit 090114, 100414, 190614, 200214, 260614, 310714
의료기기 분류등급
Neurological Devices
의료기기 등급
2
이식된 장치?
No
유통
Nationwide, Foreign
제품 설명
Integra Licox Brain Tissue Oxygen Monitoring || Integra Licox Recon Tissue Oxygen Monitoring || 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) || 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) || 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 || 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) || Sterile Rx Only || Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247
Manufacturer
Integra LifeSciences Corp.
1 Event
Device Recall LICOX Brain Oxygen Monitoring System 의 리콜
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제조사
Integra LifeSciences Corp.
제조사 주소
Integra LifeSciences Corp., 311 Enterprise Dr, Plainsboro NJ 08536-3344
제조사 모회사 (2017)
Integra LifeSciences Holdings Corporation
Source
USFDA
Language
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