PMA P010040S001

Device: THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE
Applicant: Redhawk Medical Products & Services, LLC
PMA number: P010040
Supplement: S001
Product code: MTV
Decision date: 2002-04-18
Classification: General Hospital
Generic name: Sharps needle destruction device
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.

Current openFDA PMA Record#

Device: THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE
Applicant: Redhawk Medical Products & Services, LLC
PMA number: P010040
Supplement: S001
Product code: MTV
Generic name: Sharps needle destruction device
Decision date: 2002-04-18
Decision code: APPR
Date received: 2002-04-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.