Home GUDID 00810021380438 GMA 2.0 Pedicle Screw System
Primary DI 00810021380438
Brand GMA 2.0 Pedicle Screw System
Company GRAFTON MEDICAL ALLIANCE, INC.
Model PSS-DRIVER-12
Catalog number PSS-DRIVER-12
Device description GMA Pedicle Screw Driver Assembly
Published 2020-01-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 00810021380438 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 00810021380438 00810021380438 810021380438 0810021380438
GMDN Terms# Term, Definition table Term Definition Surgical screwdriver, reusable A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 063381119 Device count 1 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 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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