Home GUDID 00813892021011 Outologous Spinal Fixation System
Primary DI 00813892021011
Brand Outologous Spinal Fixation System
Company Orthopedic Sciences Inc
Model TL1040
Catalog number TL1040
Device description 40mm Cross Link
Published 2015-10-13
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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00813892021011 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 00813892021011 00813892021011 813892021011 0813892021011
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 Length 40 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep at room temperature Storage Environment Temperature 0 Degrees Fahrenheit 122 Degrees Fahrenheit
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 068109169 Device count 1 DM exempt true 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 00813892020779 Outologous Spinal Fixation System PS6030 PS6030 2015-10-13 00813892020786 Outologous Spinal Fixation System PS6035 PS6035 2015-10-13 00813892020793 Outologous Spinal Fixation System PS6040 PS6040 2015-10-13 00813892020809 Outologous Spinal Fixation System PS6045 PS6045 2015-10-13 00813892020816 Outologous Spinal Fixation System PS6050 PS6050 2015-10-13 00813892020823 Outologous Spinal Fixation System PS6055 PS6055 2015-10-13 00813892020830 Outologous Spinal Fixation System PS6060 PS6060 2015-10-13 00813892020847 Outologous Spinal Fixation System PS7030 PS7030 2015-10-13 00813892020854 Outologous Spinal Fixation System PS7035 PS7035 2015-10-13 00813892020861 Outologous Spinal Fixation System PS7040 PS7040 2015-10-13 00813892020878 Outologous Spinal Fixation System PS7045 PS7045 2015-10-13 00813892020885 Outologous Spinal Fixation System PS7050 PS7050 2015-10-13 00813892020892 Outologous Spinal Fixation System PS7055 PS7055 2015-10-13 00813892020908 Outologous Spinal Fixation System PS7060 PS7060 2015-10-13 00813892020915 Outologous Spinal Fixation System RD6040 RD6040 2015-10-13 00813892020922 Outologous Spinal Fixation System RD6050 RD6050 2015-10-13 00813892020939 Outologous Spinal Fixation System RD6060 RD6060 2015-10-13 00813892020946 Outologous Spinal Fixation System RD6070 RD6070 2015-10-13 00813892020953 Outologous Spinal Fixation System RD6080 RD6080 2015-10-13 00813892020960 Outologous Spinal Fixation System RD6090 RD6090 2015-10-13
Other Devices Sharing Product Codes# 
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