Home GUDID 05420060363092 TruMatch Personalised Solutions Shoulder System
Primary DI 05420060363092
Brand TruMatch Personalised Solutions Shoulder System
Company Materialise NV
Model 225503003
Catalog number 225503003
Device description Guide and Bone model Shoulder Arthroplasty 2.5mm Center Pin
Published 2018-05-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true 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 05420060363092 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05420060363092 05420060363092 5420060363092
GMDN Terms# Term, Definition table Term Definition Custom-made orthopaedic/craniofacial surgical guide A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
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 true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 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 00811596032524 F1x Fracture Stem System CATALYST ORTHOSCIENCE INC. PHX 2026-08-25 00811596032531 F1x Fracture Stem System CATALYST ORTHOSCIENCE INC. PHX 2026-08-25