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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE
Generic NameSharps needle destruction device
Regulation Number880.6210
ApplicantRedhawk Medical Products & Services, LLC
P.O. Box 53929
Lafayette, LA 70505
PMA NumberP010040
Supplement NumberS001
Date Received04/16/2002
Decision Date04/18/2002
Reclassified Date06/04/2018
Product Code MTV 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE DEVICE TO ADD A PORT FOR DESTRUCTION OF LANCETS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DISINTEGRATOR PLUS NEEDLE DESTRUCTION UNIT AND IS INDICATED FOR HOME USE TO DESTROY 27 TO 30 GAUGE INSULIN HYPODERMIC NEEDLES FROM 5/16 TO = INCHES IN LENGTH, ATTACHED TO INSULIN PENS AND DISPOSABLE INSULIN SYRINGES OF 1/3 CC TO 1.0 CC VOLUME IN SIZE AND LANCETS.
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