Home GUDID 05420060380808 TRUMATCH
Primary DI 05420060380808
Brand TRUMATCH
Company Materialise NV
Model SD900.058
Catalog number SD900.058
Device description TRUMATCH TJR Mandible Polyamide Kit with duplicate bridge
Published 2025-09-11
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 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 05420060380808 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05420060380808 05420060380808 5420060380808
GMDN Terms# Term, Definition table Term Definition Custom-made organ/bone anatomy model/surgical guide kit A collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 373139427 Device count 1 Lot or batch 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
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