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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTHE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2
Classification Namedevice, needle destruction
Generic Namedevice, needle destruction
Applicant
HEALTHCARE PRODUCTS PLUS, INC.
2119 north kenmore ave.
chicago, IL 60614
PMA NumberP960018
Date Received05/28/1996
Decision Date07/16/1998
Product Code
MTV[ Registered Establishments with MTV ]
Docket Number 98M-0619
Notice Date 08/17/1998
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The device is indicated for use as a mobile sharps needle destruction device that is intended to oxidize non-coated stainless steel needles immediately after use. The device will oxidize to the hub butterfly-type needles and all needles 16-30 gauge and 4-52mm in length attached to a metal or plastic hub or a vacutainer. The device is intneded to be used in hospitals and other healthcare facilities.
Supplements: S001 
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