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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 NameTHE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2
Classification Namedevice, needle destruction
Generic Namesharps needle destruction device
ApplicantHEALTHCARE PRODUCTS PLUS, INC.
PMA NumberP960018
Date Received05/28/1996
Decision Date07/16/1998
Product Code
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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