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Device | THE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2 |
Generic Name | Sharps needle destruction device |
Regulation Number | 880.6210 |
Applicant | HEALTHCARE PRODUCTS PLUS, INC. 2119 NORTH KENMORE AVE. CHICAGO, IL 60614 |
PMA Number | P960018 |
Date Received | 05/28/1996 |
Decision Date | 07/16/1998 |
Reclassified Date
|
06/04/2018 |
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 |