Devices

Device Recall Henry Schein Explorer Single End 23

Model / Serial
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.
Product Classification
Dental Devices
Device Class
1
Implanted device?
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.
Product Description
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
Hu-Friedy Mfg Co, Inc.
1 Event
- Recall of Device Recall Henry Schein Explorer Single End 23

Manufacturer

Hu-Friedy Mfg Co, Inc.

Manufacturer Address
Hu-Friedy Mfg Co, Inc., 3232 N Rockwell St, Chicago IL 60618-5944
Source
USFDA

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