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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.
Classification Namedevice, needle destruction
Generic Namedevice, needle destruction
RedHawk Medical Products & Services LLC
p.o. box 53929
lafayette, LA 70505-3929
PMA NumberP010040
Supplement NumberS002
Date Received02/24/2003
Decision Date04/04/2003
Product Code
MTV[ Registered Establishments with 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.