Home GUDID 00196449002610 LEOS Cannulated Screw System
Primary DI 00196449002610
Brand LEOS Cannulated Screw System
Company Tyber Medical, LLC
Model 76312028
Catalog number 76312028
Device description LEOS 2.0 X 28mm HD Cann Screw, Ti
Published 2023-12-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name HWC Screw, fixation, bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWC Screw, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00196449002610 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00196449002610 00196449002610 196449002610 0196449002610
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone screw (non-sliding) A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.
Regulatory Flags# DUNS number 010968002 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00196449010219 A.L.P.S. mvX™ 770024010 770024010 2023-12-15 00196449012800 A.L.P.S. mvX™ 770024020 770024020 2023-12-15 00196449002511 LEOS Cannulated Screw System 76312008 76312008 2023-12-08 00196449002528 LEOS Cannulated Screw System 76312010 76312010 2023-12-08 00196449002535 LEOS Cannulated Screw System 76312012 76312012 2023-12-08 00196449002542 LEOS Cannulated Screw System 76312014 76312014 2023-12-08 00196449002559 LEOS Cannulated Screw System 76312016 76312016 2023-12-08 00196449002566 LEOS Cannulated Screw System 76312018 76312018 2023-12-08 00196449002573 LEOS Cannulated Screw System 76312020 76312020 2023-12-08 00196449002580 LEOS Cannulated Screw System 76312022 76312022 2023-12-08 00196449002597 LEOS Cannulated Screw System 76312024 76312024 2023-12-08 00196449002603 LEOS Cannulated Screw System 76312026 76312026 2023-12-08 00196449002627 LEOS Cannulated Screw System 76312030 76312030 2023-12-08 00196449002634 LEOS Cannulated Screw System 76312508 76312508 2023-12-08 00196449002641 LEOS Cannulated Screw System 76312510 76312510 2023-12-08 00196449002658 LEOS Cannulated Screw System 76312512 76312512 2023-12-08 00196449002665 LEOS Cannulated Screw System 76312514 76312514 2023-12-08 00196449002672 LEOS Cannulated Screw System 76312516 76312516 2023-12-08 00196449002689 LEOS Cannulated Screw System 76312518 76312518 2023-12-08 00196449002696 LEOS Cannulated Screw System 76312520 76312520 2023-12-08
Other Devices Sharing Product Codes# 
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