Home GUDID 00840097509846 restor3d Total Talus Replacement
Primary DI 00840097509846
Brand restor3d Total Talus Replacement
Company Restor3d, Inc.
Model 6102-201
Device description Trial, Total Talus, 90%
Published 2024-03-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name QNN Prosthesis, Total Talus Replacement, Metal QYQ Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QNN Prosthesis, Total Talus Replacement, Metal Unknown f QYQ Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal Unknown f
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840097509846 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 00840097509846 00840097509846 840097509846 0840097509846
GMDN Terms# Term, Definition table Term Definition Custom-made hand/foot bone prosthesis An implantable device designed and created for a specific patient to replace the whole or part of a bone in the hand or foot, including the wrist or ankle (e.g., carpal, metacarpal, tarsal or metatarsal bones), typically to treat avascular necrosis or other osteolytic conditions. It is made of metal [e.g., titanium (Ti) alloy]. Devices intended to assist implantation (e.g., trial prosthesis, surgical guide) may be included with the prosthesis.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080819836 Device count 1 Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840097509747 restor3d Total Talus Replacement Restor3d, Inc. QNN 2024-03-15 00840097509754 restor3d Total Talus Replacement Restor3d, Inc. QNN 2024-03-15 00840097509761 restor3d Total Talus Replacement Restor3d, Inc. QNN 2024-03-15 00840097509778 restor3d Total Talus Replacement Restor3d, Inc. QNN 2024-03-15 00840097509785 restor3d Total Talus Replacement Restor3d, Inc. QNN 2024-03-15 00840097509792 restor3d Total Talus Replacement Restor3d, Inc. QYQ 2024-03-15 00840097509808 restor3d Total Talus Replacement Restor3d, Inc. QYQ 2024-03-15 00840097509815 restor3d Total Talus Replacement Restor3d, Inc. QYQ 2024-03-15 00840097509822 restor3d Total Talus Replacement Restor3d, Inc. QYQ 2024-03-15 00840097509839 restor3d Total Talus Replacement Restor3d, Inc. QYQ 2024-03-15 00840097509853 restor3d Total Talus Replacement Restor3d, Inc. QYQ 2024-03-15 00840097509853 restor3d Total Talus Replacement Restor3d, Inc. QNN 2024-03-15 00840097509860 restor3d Total Talus Replacement Restor3d, Inc. QYQ 2024-03-15 00840097509860 restor3d Total Talus Replacement Restor3d, Inc. QNN 2024-03-15 00840097509877 restor3d Total Talus Replacement Restor3d, Inc. QYQ 2024-03-15 00840097509877 restor3d Total Talus Replacement Restor3d, Inc. QNN 2024-03-15 00840097509884 restor3d Total Talus Replacement Restor3d, Inc. QYQ 2024-03-15 00840097509884 restor3d Total Talus Replacement Restor3d, Inc. QNN 2024-03-15 00840097509891 restor3d Total Talus Replacement Restor3d, Inc. QYQ 2024-03-15 00840097509891 restor3d Total Talus Replacement Restor3d, Inc. QNN 2024-03-15 00840097509907 restor3d Total Talus Replacement Restor3d, Inc. QNN 2024-03-15 00840097509907 restor3d Total Talus Replacement Restor3d, Inc. QYQ 2024-03-15 00889795128119 Patient Specific Talus Spacer Paragon 28, Inc. QNN 2024-03-07 00889795128126 Patient Specific Talus Spacer Paragon 28, Inc. QNN 2024-03-07 00889795128133 Patient Specific Talus Spacer Paragon 28, Inc. QNN 2024-03-07 00889795128768 Patient Specific Talus Spacer Paragon 28, Inc. QNN 2024-03-07 00889795128775 Patient Specific Talus Spacer Paragon 28, Inc. QNN 2024-03-07 00889795128782 Patient Specific Talus Spacer Paragon 28, Inc. QNN 2024-03-07 00889795137197 Patient Specific Talus Spacer Paragon 28, Inc. QNN 2024-03-07 00889795137203 Patient Specific Talus Spacer Paragon 28, Inc. QNN 2024-03-07