| 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. |
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| Device | SHARPS TERMINATOR |
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| Generic Name | Sharps needle destruction device |
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| Regulation Number | 880.6210 |
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| Applicant | SHARPS TERMINATOR, LLC
6502 SLIDE RD SUITE 402
LUBBOCK, TX 79401 |
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| PMA Number | P120018 |
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| Date Received | 10/23/2012 |
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| Decision Date | 02/17/2016 |
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|
Reclassified Date
|
06/04/2018 |
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| Product Code |
MTV |
| Docket Number | 16M-0806 |
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| Notice Date | 03/07/2016 |
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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 Sharps Terminator. This device is indicated for use by individuals and healthcare professionals to safely destroy 18-27 gauge needles up to 2 inches (approx. 5 cm). The device is for use in treatment settings such as treatment rooms, emergency/trauma rooms, wards, and medication rooms of Hospitals and Outpatient Clinics/Medical Offices, Dental Offices, and Clinical Laboratories. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 |
|
|
