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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.
 
Trade NameTHE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE
Classification Namedevice, needle destruction
Generic Namesharps needle destruction device
ApplicantSAFEGUARD MEDICAL DEVICES, INC.
PMA NumberP010040
Supplement NumberS001
Date Received04/16/2002
Decision Date04/18/2002
Product Code
MTV
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
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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