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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Trade NameNEEDLE ZAP (R)
Classification Namedevice, needle destruction
Generic Namedevice, needle destruction
PMA NumberP010065
Date Received12/18/2001
Decision Date03/14/2003
Product Code
Docket Number 03M-0115
Notice Date 03/25/2003
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the needlezap. The device is a portable needle destruction device that is indicated for use by health care professionals to destroy previously used aluminum and stainless steel needles (gauges 16 - 30,3/4- 2 inches in length) attached to syringes. The needlezap product is intended for use in health care facilities and treatment settings.
Approval Order Approval Order
Supplements: S002