Device Recall Henry Schein Explorer Double End 5

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Hu-Friedy Mfg Co, Inc., 3232 N Rockwell St, Chicago IL 60618-5944
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    Date Codes/Lot Numbers: 0503, 0603, 0903, 1003, 1103. Barcode +H658100800808.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Dental practitioners, hospitals, dental clinics and distributors located nationwide, in Puerto Rico and internationally.
  • Description du dispositif
    Dental Explorer D/E #5, Mfr. Part Code/Product Code 100-8008, 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¿ 100-8008 Explorer-Double End #5. +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).
  • Manufacturer