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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceDISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE
Classification Namedevice, needle destruction
Generic Namedevice, needle destruction
Applicant
SAFEGUARD MEDICAL TECHNOLOGIES, LLC
14200 ellsworth rd.
berlin center, OH 44401
PMA NumberP010040
Supplement NumberS002
Date Received02/24/2003
Decision Date04/04/2003
Product Code
MTV
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for clinical use of the device, the components and shielding to minimize emi levels, a higher current capacity for ac operation and two adapters to accommodate destruction of conventional needles ranging in size from 5/16 to 1 inch in length and 20-30 gauge that are attached to 1 to 3 cc syringes. The device, as modified, which will be marketed under the trade name disintegrator pro, is a sharps needle destruction device for clinical use that is indicated for the destruction of lancets and 20 to 30 gauge needles form 5/16 to 1 inch in length.
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