35111781-604c-4d12-be01-f2ba869ed5d9UpdatePublished52023-09-152015-09-202022-09-01Not in Commercial Distribution10886704040729PrimaryGS1CODMAN HOLTER82-1693821693607846297Cerenovus, Inc.1CODMAN HOLTERPeritoneal Catheter Placement InstrumentfalsetruefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xx46800Subcutaneous tunneller, reusableA 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.falseActiveJXGShunt, central nervous system and componentsfalsetrueMoist Heat or Steam Sterilization