PMA P010040

Device: DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE
Applicant: Redhawk Medical Products & Services, LLC
PMA number: P010040
Supplement: S002
Product code: MTV
Decision date: 2003-04-04
Classification: General Hospital
Generic name: Sharps needle destruction device
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.

Current openFDA PMA Record#

Device: DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE
Applicant: Redhawk Medical Products & Services, LLC
PMA number: P010040
Supplement: S002
Product code: MTV
Generic name: Sharps needle destruction device
Decision date: 2003-04-04
Decision code: APPR
Date received: 2003-02-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.