Home GUDID 05404028001288 SurgiCase Planner
Primary DI 05404028001288
Brand SurgiCase Planner
Company Materialise NV
Model SurgiCase Shoulder Planner
Catalog number SurgiCase Shoulder Planner
Device description SurgiCase Shoulder Planner
Published 2026-07-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented PHX Shoulder Prosthesis, Reverse Configuration QHE Shoulder Arthroplasty Implantation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic 2 PHX Shoulder Prosthesis, Reverse Configuration Orthopedic 2 QHE Shoulder Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05404028001288 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05404028001288 05404028001288 5404028001288
GMDN Terms# Term, Definition table Term Definition CAD/CAM software A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.
Regulatory Flags# DUNS number 373139427 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 03701037320440 FX V135 Shoulder Prosthesis FX SOLUTIONS PHX 2026-09-22 03701037321188 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FX SOLUTIONS PHX 2026-09-22 00840097533919 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533926 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533933 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533940 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533957 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533964 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533971 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533988 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533995 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097534008 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097534015 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097534022 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 B1132N2GI200050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI200100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI206000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI208000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI220050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI220100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI226000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI228000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI240050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI240100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI246000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI248000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI270050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI270100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI276000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI278000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18