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. |
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Device | DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE |
Generic Name | Sharps needle destruction device |
Regulation Number | 880.6210 |
Applicant | RedHawk Medical Products & Services LLC P.O. Box 53929 Lafayette, LA 70505-3929 |
PMA Number | P010040 |
Supplement Number | S002 |
Date Received | 02/24/2003 |
Decision Date | 04/04/2003 |
Reclassified Date
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06/04/2018 |
Product Code |
MTV |
Advisory Committee |
General Hospital |
Supplement Type | Normal 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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