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.
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.
| Device | THE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2 |
| Generic Name | Sharps Needle Destruction Device |
| Applicant | HEALTHCARE PRODUCTS PLUS, INC. |
| Date Received | 1996-05-28 |
| Decision Date | 1998-07-16 |
| Notice Date | 1998-08-17 |
| PMA | P960018 |
| Supplement | S |
| Product Code | MTV |
| Docket Number | 98M-0619 |
| Advisory Committee | General Hospital |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HEALTHCARE PRODUCTS PLUS, INC. 2119 North Kenmore Ave. chicago, IL 60614 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960018 | Original Filing | |
| S001 | 1998-10-14 | Normal 180 Day Track |