THE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2
FDA premarket approval P960018 · decided 1998-07-16
Approval details
- PMA number
- P960018
- Trade name
- 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
- Days to decision
- 779 days
- Decision code
- APRL
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Chicago, IL
- 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.
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