Home GUDID 05420060380204 TruMatch
Primary DI 05420060380204
Brand TruMatch
Company Materialise NV
Model SD980.020
Catalog number SD980.020
Device description TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Mandible, Medium
Published 2017-08-31
Public version status Update
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 JEY Plate, Bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JEY Plate, Bone Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05420060380204 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05420060380204 05420060380204 5420060380204
GMDN Terms# Term, Definition table Term Definition Cranial bone prosthesis, custom-made A sterile implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 373139427 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05404028001288 SurgiCase Planner SurgiCase Shoulder Planner SurgiCase Shoulder Planner 2026-07-16 05404028001257 SurgiCase Planner SurgiCase Knee Planner SurgiCase Knee Planner 2026-05-28 05404028007006 OrthoView OrthoView OrthoView 2026-05-22 05404028001196 Mimics Cardiac Planner Mimics Cardiac Planner TAVR Mimics Cardiac Planner TAVR 2026-05-15 05420060350856 TruMatch CMF Titanium 3D Printed Guides SD980.060 SD980.060 2026-04-29 05420060351631 TruMatch CMF Titanium 3D Printed Guides SD980.064 SD980.064 2026-04-29 05420060351648 TruMatch CMF Titanium 3D Printed Guides SD980.065 SD980.065 2026-04-29 05404028001202 Mimics Automatic Algorithms Mimics Automatic Algorithms CMF Orthognathic CT CB Mimics Automatic Algorithms CMF Orthognathic CT CB 2026-04-20 05404028001219 Mimics Automatic Algorithms Mimics Automatic Algorithms CMF Reconstruction CT Mimics Automatic Algorithms CMF Reconstruction CT 2026-04-20 05404028001226 Mimics Automatic Algorithms Mimics Automatic Algorithms Knee MRI Mimics Automatic Algorithms Knee MRI 2026-04-20 05404028001080 Materialise Mimics Enlight CMF Orthognathic and Trauma Planner Orthognathic and Trauma Planner 2026-04-10 05404028001097 Materialise Mimics Enlight CMF Reconstruction Planner Reconstruction Planner 2026-04-10 05404028001103 Materialise Mimics Enlight CMF Splint Designer Splint Designer 2026-04-10 05404028001158 Mimics Flow Mimics Flow Mimics Flow 2026-03-23 05404028001172 SurgiCase Online SurgiCase Online SurgiCase Online 2026-03-23 05404028001189 ProPlan CMF ProPlan CMF Online ProPlan CMF Online 2026-03-23 05404028000861 Mimics Thoracic Planner Mimics Thoracic Planner Mimics Thoracic Planner 2026-03-20 05420060360015 BKS Total PSI KNM-OD01-00-01 KNM-OD01-00-01 2022-09-21 05420060310027 Zimmer Biomet Patient Specific Instruments KNM-ZB02-00-01 KNM-ZB02-00-01 2018-08-11 05420060310034 Zimmer Biomet Patient Specific Instruments KNM-ZB03-00-01 KNM-ZB03-00-01 2018-08-11
Other Devices Sharing Product Codes#