Home GUDID 00841732120426 RAPHAEL Pedicle Screw System
Primary DI 00841732120426
Brand RAPHAEL Pedicle Screw System
Company CTL Medical Corporation
Model 015.3633
Device description RAPHAEL™ Polyaxial Screw, LX, Cannulated, D8.5 x L30mm
Published 2017-08-08
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 00841732120426 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 00841732120426 00841732120426 841732120426 0841732120426
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.
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 00841732168091 MONDRIAN ALIF Cage with Supplementary Fixation Plate 120.8700 2026-08-14 00841732168107 MONDRIAN ALIF Cage with Supplementary Fixation Plate 120.8704 2026-08-14 00841732168114 MONDRIAN ALIF Cage with Supplementary Fixation Plate 120.8701 2026-08-14 00841732168121 MONDRIAN ALIF Cage with Supplementary Fixation Plate 120.8702 2026-08-14 00841732168138 MONDRIAN ALIF Cage with Supplementary Fixation Plate 120.8703 2026-08-14 00841732168527 TAURUS Pedicle Screw System 059.8013 2026-07-28 00841732169272 PICASSO MIS Spinal System 016.3160 2026-07-24 00841732169289 PICASSO MIS Spinal System 016.3170 2026-07-24 00841732169296 PICASSO MIS Spinal System 016.3180 2026-07-24 00841732169302 PICASSO MIS Spinal System 016.3190 2026-07-24 00841732169319 PICASSO MIS Spinal System 016.3200 2026-07-24 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
Other Devices Sharing Product Codes# 
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