Home GUDID E314C0039000000011000 SurgiCase
Primary DI E314C0039000000011000
Brand SurgiCase
Company Materialise NV
Model C-00-3-900000-0011-000
Catalog number C-00-3-900000-0011-000
Device description Anatomical model
Published 2016-09-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name HWT Template
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWT Template Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status E314C0039000000011000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Custom-made organ/bone anatomy model A model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 373139427 Device count 1 Premarket exempt true 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#