Home GUDID E31442433550 Signature
Primary DI E31442433550
Brand Signature
Company Materialise NV
Model 42-433550
Catalog number 42-433550
Device description SIG XP GDE/MDL SET 03-00
Published 2026-09-24
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 true Product Codes# Code, Name table Code Name JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OOG Knee Arthroplasty Implantation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2 MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic 2 MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer Orthopedic 2 OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic 2 OOG Knee Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status E31442433550 Primary HIBCC 0
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 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 false 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 00840097536705 Identity CR KA Restor3d, Inc. OIY 2026-09-25 00840097536705 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536705 Identity CR KA Restor3d, Inc. OOG 2026-09-25 00840097536712 Identity CR KA Restor3d, Inc. OOG 2026-09-25 00840097536712 Identity CR KA Restor3d, Inc. OIY 2026-09-25 00840097536712 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25