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Devices
Device Recall PT Graphix Intermediate PTCA Guide Wire
모델명 / 제조번호(시리얼번호)
Individual devices in pouches as follows: Catalog No. 14914-01 UPN H74914914011 Lot Number Expiration Date 4772607 2004-0 4772610 '' 4762379 '' 4762384 '' 4772618 '' 4766619 '' 4758393 '' 4758432 '' 4753775 '' 4758389 '' 4758427 '' 4756521 '' 4762390 '' 4756485 '' 4753781 '' 4758397 '' 4758423 '' 4753783 '' 4753785 '' 4740328 2004-4 4753779 2004-5 4753759 '' 4753769 '' 4756534 '' 4756536 '' 4756531 '' 4724690 2004-4 4740329 '' 4736552 '' The above PT Graphix¿ guide wire pouch lots were packaged in 18 lots of five-pack boxes with the following codes: Catalog No. 1215T UPN H74914914012 Lot Number Expiration Date 4789558 2004-05 4791600 '' 4789558 '' 4791126 '' 4785009 '' 4787988 '' 4786427 '' 4783177 '' 4780051 '' 4780186 '' 4783316 '' 4780190 '' 4782079 '' 4780939 '' 4771889 '' 4777410 '' 4775761 '' 4776272 '' 4766792 ''
의료기기 분류등급
Cardiovascular Devices
의료기기 등급
2
이식된 장치?
No
유통
Recalled product was shipped to 107 domestic hosptials nationwide and to 2 international acccounts.
제품 설명
Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300 cm length.
Manufacturer
Symbiosis Corp.
1 Event
Device Recall PT Graphix Intermediate PTCA Guide Wire 의 리콜
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제조사
Symbiosis Corp.
제조사 주소
Symbiosis Corp., 8600 NW 41th Street, Miami FL 33166
Source
USFDA
Language
English
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