Home GUDID 00841732117945 PICASSO II MIS Spinal System
Primary DI 00841732117945
Brand PICASSO II MIS Spinal System
Company CTL Medical Corporation
Model 119.1745
Device description PICASSO™ II Percutaneous Polyaxial Screw, Semi-Closed 127mm, D7.5xL45mm
Published 2023-09-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
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 00841732117945 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 00841732117945 00841732117945 841732117945 0841732117945
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 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 true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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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