Home GUDID 00816847022538 VSP Orthopedics
Primary DI 00816847022538
Brand VSP Orthopedics
Company 3D SYSTEMS, INC.
Model Orthopedic Implant Template
Device description A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
Published 2019-09-11
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Single use true Product Codes# Code, Name table Code Name PBF Orthopaedic Surgical Planning And Instrument Guides
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816847022538 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816847022538 00816847022538 816847022538 0816847022538
GMDN Terms# Term, Definition table Term Definition Surgical implant template, single-use A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 085049749 Device count 1 Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00816847022859 VSP PEEK Host Skull Model 2025-11-10 00816847022736 Salto Talaris Flat Cut Total Ankle System Tibia Cutting Guide 2025-01-10 00816847022743 Salto Talaris Flat Cut Total Ankle System Talus Cutting Guide 2025-01-10 00816847022750 Salto Talaris Flat Cut Total Ankle System Anatomical Model 2025-01-10 00816847022767 Cadence Flat Cut Total Ankle System Talus Cutting Guide 2025-01-10 00816847022774 Cadence Flat Cut Total Ankle System Tibia Cutting Guide 2025-01-10 00816847022781 Cadence Flat Cut Total Ankle System Anatomical model 2025-01-10 00816847022637 Cadence Chamfer Cut Total Ankle System Anatomical model 2024-09-12 00816847022651 Salto Talaris Chamfer Cut Total Ankle System Anatomical Model 2024-09-12 00816847022675 VSP PEEK Cranial Implant 2024-09-12 00816847022699 Salto Talaris Chamfer Cut Total Ankle System Talus Cutting Guide 2024-09-12 00816847022705 Salto Talaris Chamfer Cut Total Ankle System Tibia Cutting Guide 2024-09-12 00816847022712 Cadence Chamfer Cut Total Ankle System Talus Cutting Guide 2024-09-12 00816847022729 Cadence Chamfer Cut Total Ankle System Tibia Cutting Guide 2024-09-12 00816847022798 Vantage 3D PSI Tibia Cutting Guide 2024-08-05 00816847022804 Vantage 3D PSI Talus Cutting Guide 2024-08-05 00816847022811 Vantage 3D PSI Anatomical Model 2024-08-05 00816847022828 Vantage 3D+ PSI Tibia Cutting Guide 2024-08-05 00816847022835 Vantage 3D+ PSI Talus Cutting Guide 2024-08-05 00816847022842 Vantage 3D+ PSI Anatomical Model 2024-08-05
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