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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device penile implant surgical accessories
Definition Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing.
Product CodeQGA
Regulation Number 876.3500
Device Class 1

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