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U.S. Department of Health and Human Services

Product Classification

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Device sharps needle destruction device
Regulation Description Sharps needle destruction device.
Definition A prescription device that is intended to destroy needles or sharps used for medical purposes by incineration or mechanical means.
Physical State Sharps needle destruction devices are typically electrical devices that  can destruct sharps and/or needles in a variety of methods (grinding,  incinerating, etc.) that can be either portable or stationary. Some of  these devices may also employ software to provide the user with greater  control.
Technical Method Needles or sharps are placed into the device.
Target Area n/a
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeMTV
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery (DHT4B)
Submission Type 510(k)
Regulation Number 880.6210
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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