| 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. |
| |
| Device | NEEDLE ZAP (R) |
|---|
| Generic Name | Sharps needle destruction device |
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| Regulation Number | 880.6210 |
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| Applicant | E MED FUTURE
354 S. CLAY STREET
MILLERSBURG, OH 44654 |
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| PMA Number | P010065 |
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| Date Received | 12/18/2001 |
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| Decision Date | 03/14/2003 |
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|
Reclassified Date
|
06/04/2018 |
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| Product Code |
MTV |
| Docket Number | 03M-0115 |
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| Notice Date | 03/25/2003 |
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| Advisory Committee |
General Hospital |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE NEEDLEZAP. THE DEVICE IS A PORTABLE NEEDLE DESTRUCTION DEVICE THAT IS INDICATED FOR USE BY HEALTH CARE PROFESSIONALS TO DESTROY PREVIOUSLY USED ALUMINUM AND STAINLESS STEEL NEEDLES (GAUGES 16 - 30,3/4- 2 INCHES IN LENGTH) ATTACHED TO SYRINGES. THE NEEDLEZAP PRODUCT IS INTENDED FOR USE IN HEALTH CARE FACILITIES AND TREATMENT SETTINGS. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S002 |
|
|
