Device Recall Henry Schein Explorer Single End 23

  • 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
  • 1 Event

제조사

  • 제조사 주소
    Hu-Friedy Mfg Co, Inc., 3232 N Rockwell St, Chicago IL 60618-5944
  • Source
    USFDA