Device typeSubcutaneous tunneller, reusable: A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt, retinal chip). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a reusable device intended to be sterilized prior to use.
FDA categoryStainless Steel Instrument, Shunt System Implantation
Device ID00842180164826
Catalog number25-1011SM-64
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information