Home GUDID 00841732116597 RAPHAEL Pedicle Screw System
Primary DI 00841732116597
Brand RAPHAEL Pedicle Screw System
Company CTL Medical Corporation
Model 115.5450
Device description RAPHAEL Polyaxial 40mm Reduction Screw, Cortical, Cannulated, 5.5 x L50mm
Published 2016-09-18
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 KWP Appliance, Fixation, Spinal Interlaminal MNH Orthosis, spondylolisthesis spinal fixation MNI Orthosis, Spinal Pedicle Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841732116597 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 00841732116597 00841732116597 841732116597 0841732116597
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Length 50 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080138504 Device count 1 Lot or batch true Manufacturing date on label 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# 
ctlamedica.com
ctlmed.com