Home GUDID 00841732114487 GENERIC Surgical Instruments
Primary DI 00841732114487
Brand GENERIC Surgical Instruments
Company CTL Medical Corporation
Model 015.7051
Device description Alignment Tool, Polyaxial Screw
Published 2023-09-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name KWQ Appliance, Fixation, Spinal Intervertebral Body LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2 LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841732114487 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 00841732114487 00841732114487 841732114487 0841732114487
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 Premarket exempt true 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 00841732155671 VALEO II PL OL Interbody Fusion System 12.301.1012 2023-09-27 00841732155688 VALEO II PL OL Interbody Fusion System 12.301.1013 2023-09-27 00841732155695 VALEO II PL OL Interbody Fusion System 12.301.1015 2023-09-27 00841732155701 VALEO II PL OL Interbody Fusion System 12.301.1014 2023-09-27 00841732155718 VALEO II PL OL Interbody Fusion System 12.301.1016 2023-09-27 00841732155725 VALEO II PL OL Interbody Fusion System 12.301.1508 2023-09-27 00841732155732 VALEO II PL OL Interbody Fusion System 12.301.1509 2023-09-27 00841732155749 VALEO II PL OL Interbody Fusion System 12.301.1510 2023-09-27 00841732155756 VALEO II PL OL Interbody Fusion System 12.301.1511 2023-09-27 00841732155763 VALEO II PL OL Interbody Fusion System 12.301.1512 2023-09-27 00841732155770 VALEO II PL OL Interbody Fusion System 12.301.1513 2023-09-27 00841732155787 VALEO II PL OL Interbody Fusion System 12.301.1514 2023-09-27 00841732155794 VALEO II PL OL Interbody Fusion System 12.301.1515 2023-09-27 00841732155800 VALEO II PL OL Interbody Fusion System 12.301.1516 2023-09-27 00841732156135 VALEO II PL OL Interbody Fusion System 12.301.2007 2023-09-27 00841732156142 VALEO II PL OL Interbody Fusion System 12.301.2008 2023-09-27 00841732156159 VALEO II PL OL Interbody Fusion System 12.301.2009 2023-09-27 00841732156166 VALEO II PL OL Interbody Fusion System 12.301.2010 2023-09-27 00841732156173 VALEO II PL OL Interbody Fusion System 12.301.2011 2023-09-27 00841732156180 VALEO II PL OL Interbody Fusion System 12.301.2012 2023-09-27
Other Devices Sharing Product Codes# 
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