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Devices
Celsius Thermocool products and Navistar Thermocool products
모델명 / 제조번호(시리얼번호)
Lots 13027030 to 13044734
의료기기 분류등급
Cardiovascular Devices
의료기기 등급
3
이식된 장치?
No
유통
FL, iL, MA, MI, OH, OK and Belguin, Netherlands, Australia, Japan, Korea, India, Sri Lanka, New Zealand, China, Hong Kong, Singapore, Pakistan, Canada
제품 설명
Thermocool Irrigated Catheters || Celsius || LABEL US Part Number# EU CATALOG # || L-1189-01-S D17TCBLRT 35Q-13R PMA; || L-1189-02-S D17TCDLRT 35Q-33R PMA; || L-1189-03-S D17TCFLRT 35Q-53R PMA; || L-1189-04-S D17TCJLRT 35Q-73R PMA; || L-1189-15-S D71TCB5L252RT 35Q-17Q EXPORT; || L-1189-16-S D71TCD5L252RT 35Q-37Q EXPORT; || L-1189-17-S D71TCF5L252FT 35Q-57Q EXPORT; || L-1189-03-S D71TFL252RT 35R-53R EXPORT; || L-1192-03-S D71TFL252RT 35R-53R EXPORT; || L-1192-15-S D71TB5L252RT 35R-17R EXPORT; || L-1192-16-S D7ITD5L252RT 35R-37R EXPORT; || L-1189-02-SI D17TCDLRTI N/A IDE; || L-1189-15-SI D71TCB5L252RTI N/A IDE; || L-1189-16-SI D71TCD5L252RTI N/A IDE; || L-1189-17-SI D71CF5L252RTI N/A IDE || Navistar || LABEL US Part Number# EU CATALOG # || L-1192-17-S D71TF5L252RT 35R-57R EXPORT; || L-1197-14-S NI75TCBH 34H-17M PMA; || L-1197-15-S NI75TCCH 34H-27M PMA; || L-1197-16-S NI75TCDH 34H-37M PMA; || L-1197-17-S NI75TCFH 34H-57M PMA; || L-1197-18-S NI75TCJH 34H-J7M PMA; || L-1208-05-S NS75TBCT252HS 34G-17M PMA; || L-1208-06-S NS75TCCT252HS 34G-27M PMA; || L-1208-07-S NS75TDCT252HS 34G-37M PMA; || L-1208-08-S NS75TFCT252HS 34G-57M PMA; || L-1197-14-SI NI75TCBHI N/A IDE; || L-1197-15-SI NI75TCCHI N/A IDE; || L-1197-16-SI NI75TCDHI N/A IDE; || L-1197-17-SI NI75TCFHI N/A IDE; || L-1197-18-SI NI75TCJHI N/A IDE; || L-1208-05-SI NS75TBCT252HSI N/A IDE; || L-1208-06-SI NS75TCCT252HSI N/A IDE; || L-1208-07-SI NS75TDCT252HSI N/A IDE; || L-1208-08-SI NS75TFCT252HSI N/A IDE
Manufacturer
Biosense Webster, Inc.
1 Event
Celsius Thermocool products and Navistar Thermocool products 의 리콜
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제조사
Biosense Webster, Inc.
제조사 주소
Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
제조사 모회사 (2017)
Johnson & Johnson
Source
USFDA
Language
English
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