Home GUDID 00841732117907 PICASSO II
Primary DI 00841732117907
Brand PICASSO II
Company CTL Medical Corporation
Model 119.1640
Device description PICASSO™ II Percutaneous Polyaxial Screw, Semi-Closed 127mm, D6.5xL40mm
Published 2023-09-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name MNH Orthosis, Spondylolisthesis Spinal Fixation MNI Orthosis, Spinal Pedicle Fixation NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841732117907 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 00841732117907 00841732117907 841732117907 0841732117907
GMDN Terms# Term, Definition table Term Definition Spinal bone screw, non-bioabsorbable A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080138504 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 00841732155671 VALEO II PL OL Interbody Fusion System 12.301.1012 2023-09-27 00841732155688 VALEO II PL OL Interbody Fusion System 12.301.1013 2023-09-27 00841732155695 VALEO II PL OL Interbody Fusion System 12.301.1015 2023-09-27 00841732155701 VALEO II PL OL Interbody Fusion System 12.301.1014 2023-09-27 00841732155718 VALEO II PL OL Interbody Fusion System 12.301.1016 2023-09-27 00841732155725 VALEO II PL OL Interbody Fusion System 12.301.1508 2023-09-27 00841732155732 VALEO II PL OL Interbody Fusion System 12.301.1509 2023-09-27 00841732155749 VALEO II PL OL Interbody Fusion System 12.301.1510 2023-09-27 00841732155756 VALEO II PL OL Interbody Fusion System 12.301.1511 2023-09-27 00841732155763 VALEO II PL OL Interbody Fusion System 12.301.1512 2023-09-27 00841732155770 VALEO II PL OL Interbody Fusion System 12.301.1513 2023-09-27 00841732155787 VALEO II PL OL Interbody Fusion System 12.301.1514 2023-09-27 00841732155794 VALEO II PL OL Interbody Fusion System 12.301.1515 2023-09-27 00841732155800 VALEO II PL OL Interbody Fusion System 12.301.1516 2023-09-27 00841732156135 VALEO II PL OL Interbody Fusion System 12.301.2007 2023-09-27 00841732156142 VALEO II PL OL Interbody Fusion System 12.301.2008 2023-09-27 00841732156159 VALEO II PL OL Interbody Fusion System 12.301.2009 2023-09-27 00841732156166 VALEO II PL OL Interbody Fusion System 12.301.2010 2023-09-27 00841732156173 VALEO II PL OL Interbody Fusion System 12.301.2011 2023-09-27 00841732156180 VALEO II PL OL Interbody Fusion System 12.301.2012 2023-09-27
Other Devices Sharing Product Codes# 
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