Home GUDID 00841732115286 RAPHAEL Pedicle Screw System
Primary DI 00841732115286
Brand RAPHAEL Pedicle Screw System
Company CTL Medical Corporation
Model 115.1630
Device description RAPHAEL Polyaxial Screw, Cortical, Cannulated, 6.5 x L30mm
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 00841732115286 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 00841732115286 00841732115286 841732115286 0841732115286
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 30 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 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 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
Other Devices Sharing Product Codes# 
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