Home GUDID 00816847021906 VSP Orthopedics
Primary DI 00816847021906
Brand VSP Orthopedics
Company 3D SYSTEMS, INC.
Model Allograft Pelvic Drilling Guide
Device description A physical guide that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
Published 2019-09-11
Public version status Update
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 00816847021906 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 00816847021906 00816847021906 816847021906 0816847021906
GMDN Terms# Term, Definition table Term Definition Custom-made orthopaedic surgical guide, non-sterile A non-sterile, 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 made of synthetic polymer materials and 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 intended to be sterilized prior to use.
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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07630345779939 NextAR Spine Platform Medacta International SA PBF 2023-07-24 07630345797063 NextAR Spine Platform Medacta International SA PBF 2023-07-24 07630345797070 NextAR Spine Platform Medacta International SA PBF 2023-07-24 07630345797087 NextAR Spine Platform Medacta International SA PBF 2023-07-24 G2710300240140 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240150 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240160 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240180 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240190 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240200 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240210 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240220 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240230 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240240 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240250 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260150 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260160 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260170 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260180 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260190 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260200 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260210 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260220 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260230 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260240 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260250 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310280150 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310280160 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310280170 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310280180 Intelliguides Mios Marketing, LLC PBF 2023-01-01