Home GUDID E314SHCLM010001 Lima PSI
Primary DI E314SHCLM010001
Brand Lima PSI
Company Materialise NV
Model SHC-LM01-00-01
Catalog number SHC-LM01-00-01
Device description Lima CT RSA guide and bone model
Published 2016-12-01
Public version status Update
Distribution status Not 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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status E314SHCLM010001 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 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 07630542795602 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 07630542795817 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 07630542795824 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 07630542795831 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 07630542795848 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 07630542795855 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 07630542795879 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 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 03661489725463 JARVIS Diaphyseal Stem Standard FOURNITURES HOSPITALIERES INDUSTRIE KWS 2026-08-03 00811596031992 EA Convertible System CATALYST ORTHOSCIENCE INC. KWS 2026-07-17 05404028001288 SurgiCase Planner Materialise NV KWS 2026-07-16 00811596031695 EA Convertible System CATALYST ORTHOSCIENCE INC. KWS 2026-07-14 00811596031701 EA Convertible System CATALYST ORTHOSCIENCE INC. KWS 2026-07-14 00811596031718 EA Convertible System CATALYST ORTHOSCIENCE INC. KWS 2026-07-14 00811596031725 EA Convertible System CATALYST ORTHOSCIENCE INC. KWS 2026-07-14