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 00841732163447 VALEO C Spacer System 91.002.4001 2023-09-30 00841732163454 VALEO C Spacer System 91.002.4002 2023-09-30 00841732163461 VALEO C Spacer System 91.002.4003 2023-09-30 00841732128231 VALEO VBR 91.009.5651 2023-09-27 00841732128248 VALEO VBR 91.009.5652 2023-09-27 00841732145511 VALEO C+CSC with Lumen Interbody Fusion Device 11.209.1707 2023-09-19 00841732145528 VALEO C+CSC with Lumen Interbody Fusion Device 11.209.1708 2023-09-19 00841732145535 VALEO C+CSC with Lumen Interbody Fusion Device 11.209.1709 2023-09-19 00841732145542 VALEO C+CSC with Lumen Interbody Fusion Device 11.209.1710 2023-09-19 00841732154766 VALEO C+CSC with Lumen Interbody Fusion Device 11.209.1108 2023-09-19 00841732154773 VALEO C+CSC with Lumen Interbody Fusion Device 11.209.1109 2023-09-19 00841732154780 VALEO C+CSC with Lumen Interbody Fusion Device 11.209.1110 2023-09-19 00841732154797 VALEO C+CSC with Lumen Interbody Fusion Device 11.209.1111 2023-09-19 00841732154803 VALEO C+CSC with Lumen Interbody Fusion Device 11.209.1705 2023-09-19 00841732154810 VALEO C+CSC with Lumen Interbody Fusion Device 11.209.1706 2023-09-19 00841732154865 VALEO C+CSC with Lumen Interbody Fusion Device 11.209.1711 2023-09-19 00841732149847 TAURUS Pedicle Screw System 51-1000-001 2023-09-15 00841732149854 TAURUS Pedicle Screw System 51-1000-002 2023-09-15 00841732150614 GENERIC Surgical Instruments 50-1000-004 2023-09-15 00841732150621 TAURUS Pedicle Screw System 51-0000-000 2023-09-15
Other Devices Sharing Product Codes# 
ctlamedica.com