Home GUDID 08033390239516 Smart SPACE SHOULDER
Primary DI 08033390239516
Brand Smart SPACE SHOULDER
Company LIMACORPORATE SPA
Model 0023.L4.N33
Catalog number 0023.L4.N33
Device description Smart SPACE SHOULDER - Glenoid 3D Positioner-LEFT4-NOT STER
Published 2023-02-18
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 MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented 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 MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic 2 QHE Shoulder Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08033390239516 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08033390239516 08033390239516 8033390239516
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 432066322 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 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 05404028001028 SurgiCase Planner Materialise NV QHE 2025-08-28 05404028001028 SurgiCase Planner Materialise NV KWS 2025-08-28 03700434023831 Blueprint TORNIER KWS 2025-06-17 03700434023831 Blueprint TORNIER QHE 2025-06-17 03700434023848 Blueprint TORNIER KWS 2025-06-17 03700434023848 Blueprint TORNIER QHE 2025-06-17 00887868554391 Signature™ Comprehensive® Orthosoft Inc KWS 2024-02-09