Device Recall Henry Schein Explorer Single End 23

  • 모델명 / 제조번호(시리얼번호)
    Date Codes/Lot Numbers: 0503, 0603, 0903, 1003, 1103, 1203. Barcode +H658100362003.
  • 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 #23 S/E, Mfr. Part Code/Product Code 100-3620, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN¿ 100-3620 Explorer-Single End #23 SE. +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).
  • Manufacturer
  • 1 Event

제조사

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