ab94bcdc-9a40-4ba6-aa22-d224ddaa9f9aNewPublished12021-05-072021-04-29In Commercial DistributionM20922862PrimaryHIBCCBioPro22862618749857BIOPRO, INC.1ONE PIECE THUMB STEM RASP 10.0MM falsefalsefalsefalsefalsefalsetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK06108900047807Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device. falseActiveLXHOrthopedic Manual Surgical InstrumentfalsetrueMoist Heat or Steam Sterilization