Home GUDID 00810021380216 GMA 2.0 Pedicle Screw System
Primary DI 00810021380216
Brand GMA 2.0 Pedicle Screw System
Company GRAFTON MEDICAL ALLIANCE, INC.
Model 101-0035-N
Catalog number 101-0035-N
Device description PRE-BENT ROD, ø5.5 X 35
Published 2019-04-25
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MNH Orthosis, Spondylolisthesis Spinal Fixation MNI Orthosis, Spinal Pedicle Fixation NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810021380216 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 00810021380216 00810021380216 810021380216 0810021380216
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 35 Millimeter Outer Diameter 5.5 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 063381119 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 00810021380018 GMA 2.0 Pedicle Screw System 601-5530-D 601-5530-D 2019-04-25 00810021380025 GMA 2.0 Pedicle Screw System 601-5535-D 601-5535-D 2019-04-25 00810021380032 GMA 2.0 Pedicle Screw System 601-5540-D 601-5540-D 2019-04-25 00810021380049 GMA 2.0 Pedicle Screw System 601-5545-D 601-5545-D 2019-04-25 00810021380056 GMA 2.0 Pedicle Screw System 601-5550-D 601-5550-D 2019-04-25 00810021380063 GMA 2.0 Pedicle Screw System 601-5555-D 601-5555-D 2019-04-25 00810021380070 GMA 2.0 Pedicle Screw System 601-6535-D 601-6535-D 2019-04-25 00810021380087 GMA 2.0 Pedicle Screw System 601-6540-D 601-6540-D 2019-04-25 00810021380094 GMA 2.0 Pedicle Screw System 601-6545-D 601-6545-D 2019-04-25 00810021380100 GMA 2.0 Pedicle Screw System 601-6550-D 601-6550-D 2019-04-25 00810021380117 GMA 2.0 Pedicle Screw System 601-6555-D 601-6555-D 2019-04-25 00810021380124 GMA 2.0 Pedicle Screw System 601-6560-D 601-6560-D 2019-04-25 00810021380131 GMA 2.0 Pedicle Screw System 601-7535-D 601-7535-D 2019-04-25 00810021380148 GMA 2.0 Pedicle Screw System 601-7540-D 601-7540-D 2019-04-25 00810021380155 GMA 2.0 Pedicle Screw System 601-7545-D 601-7545-D 2019-04-25 00810021380162 GMA 2.0 Pedicle Screw System 601-7550-D 601-7550-D 2019-04-25 00810021380179 GMA 2.0 Pedicle Screw System 601-7555-D 601-7555-D 2019-04-25 00810021380186 GMA 2.0 Pedicle Screw System 601-7560-D 601-7560-D 2019-04-25 00810021380193 GMA 2.0 Pedicle Screw System 005-5670 005-5670 2019-04-25 00810021380209 GMA 2.0 Pedicle Screw System 101-0030-N 101-0030-N 2019-04-25
Other Devices Sharing Product Codes# 
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