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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.
Classification Namedevice, needle destruction
Generic Namedevice, needle destruction
354 s. clay street
millersburg, OH 44654
PMA NumberP010065
Date Received12/18/2001
Decision Date03/14/2003
Product Code
MTV[ Registered Establishments with MTV ]
Docket Number 03M-0115
Notice Date 03/25/2003
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S002