Device Recall Henry Schein

  • 모델명 / 제조번호(시리얼번호)
    Catalog (REF #) 9004476, Lot #4163707
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to NY only
  • 제품 설명
    Henry Schein Single Use Syringe Luer-Lock, 10 mL, || Intended for use by health care professionals for general purpose fluid aspiration/injection
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 8 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    all lots are affected
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US
  • 제품 설명
    Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Date Codes/Lot Numbers: 1102, 0103 (1102 represents November 2002, & 0103 represents January 2003); Product Code/Mfr. Part Code 101-0913.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The products were sold to the sole direct account: the Own Label Distributor, Henry Schein, Inc. in Melville, NY. Henry Schein further distributed the explorers to end users nationwide and internationally. Henry Schein Divisions located in Canada, Spain, France, Germany, United Kingdom, Holland, and New Zealand who further distributed the explorers to their customers in Canada and abroad.
  • 제품 설명
    HENRY SCHEIN(R) 101-0913 Explorer #2 D/E. Barcode *+H658101091306*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing # B057701.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Date Codes/Lot Numbers: 1102, 1202, 0103 (1102 represents November 2002, 1202 represents December 2002, & 0103 represents January 2003); Product Code/Mfr. Part Code 100-3620.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The products were sold to the sole direct account: the Own Label Distributor, Henry Schein, Inc. in Melville, NY. Henry Schein further distributed the explorers to end users nationwide and internationally. Henry Schein Divisions located in Canada, Spain, France, Germany, United Kingdom, Holland, and New Zealand who further distributed the explorers to their customers in Canada and abroad.
  • 제품 설명
    HENRY SCHEIN(R) 100-3620 Explorer-Single End #23 SE. Barcode *+H658100362003*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing # B057701.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Date Codes/Lot Numbers: 0902, 1202, 0103 (0902 represents September 2002, 1202 represents December 2002, & 0103 represents January 2003); Product Code/Mfr. Part Code 100-8008.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The products were sold to the sole direct account: the Own Label Distributor, Henry Schein, Inc. in Melville, NY. Henry Schein further distributed the explorers to end users nationwide and internationally. Henry Schein Divisions located in Canada, Spain, France, Germany, United Kingdom, Holland, and New Zealand who further distributed the explorers to their customers in Canada and abroad.
  • 제품 설명
    HENRY SCHEIN(R) 100-8008 Explorer-Double End #5. Barcode *+H658100800808*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing # B057701.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Date Codes/Lot Numbers: 0503, 0603, 0903, 1003, 1103. Barcode +H658101091306.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Dental practitioners, hospitals, dental clinics and distributors located nationwide, in Puerto Rico and internationally.
  • 제품 설명
    Dental Explorer #2 D/E, Mfr. Part Code/Product Code 101-0913, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. Product is labeled in part, HENRY SCHEIN¿ 101-0913 Explorer #2 D/E. +H658101091306. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling).
  • Manufacturer
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