Home GUDID 00841732117891
PICASSO II
Primary DI 00841732117891
Brand PICASSO II
Company CTL Medical Corporation
Model 119.1635
Device description PICASSO™ II Percutaneous Polyaxial Screw, Semi-Closed 127mm, D6.5xL35mm
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 00841732117891 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 00841732117891 00841732117891 841732117891 0841732117891
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 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#