Home GUDID 00816847021425 VSP Cranial
Primary DI 00816847021425
Brand VSP Cranial
Company 3D SYSTEMS, INC.
Model Cranial Positioning Guide
Device description A physical template / guide that conforms to patients’ anatomy (Bony) to allow manipulation of free floating bony anatomy.
Published 2016-10-12
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 PPT Cranial Surgical Planning And Instrument Guides
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PPT Cranial Surgical Planning And Instrument Guides Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816847021425 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 00816847021425 00816847021425 816847021425 0816847021425
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 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# 
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