Home GUDID 00813892020847 Outologous Spinal Fixation System
Primary DI 00813892020847
Brand Outologous Spinal Fixation System
Company Orthopedic Sciences Inc
Model PS7030
Catalog number PS7030
Device description 7.0 X 30mm Titanium Pedicle Screw Self Tapping
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 00813892020847 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 00813892020847 00813892020847 813892020847 0813892020847
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 30 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 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 00813892020977 Outologous Spinal Fixation System RD6100 RD6100 2015-10-13
Other Devices Sharing Product Codes# 
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