Home GUDID 08800017282688 LOSPA IS Spinal System
Primary DI 08800017282688
Brand LOSPA IS Spinal System
Company Corentec Co., Ltd
Model ES002-0104-1
Device description Monoaxial Guided Screw Driver
Published 2018-12-14
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 KWQ Appliance, Fixation, Spinal Intervertebral Body MNH Orthosis, Spondylolisthesis Spinal Fixation MNI Orthosis, Spinal Pedicle Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2 MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800017282688 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800017282688 08800017282688 8800017282688
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 688739895 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 08800017262178 EXULT Knee Replacement System K3.IAX.4469-09T 2020-01-10 08800017262185 EXULT Knee Replacement System K3.IAX.4469-10T 2020-01-10 08800017262192 EXULT Knee Replacement System K3.IAX.4469-11T 2020-01-10 08800017262208 EXULT Knee Replacement System K3.IAX.4469-12T 2020-01-10 08800017262215 EXULT Knee Replacement System K3.IAX.4469-13T 2020-01-10 08800017262222 EXULT Knee Replacement System K3.IAX.4469-14T 2020-01-10 08800017262239 EXULT Knee Replacement System K3.IAX.4469-16T 2020-01-10 08800017262246 EXULT Knee Replacement System K3.IAX.4469-18T 2020-01-10 08800017262253 EXULT Knee Replacement System K3.IAX.4572-09T 2020-01-10 08800017262260 EXULT Knee Replacement System K3.IAX.4572-10T 2020-01-10 08800017262277 EXULT Knee Replacement System K3.IAX.4572-11T 2020-01-10 08800017262284 EXULT Knee Replacement System K3.IAX.4572-12T 2020-01-10 08800017262291 EXULT Knee Replacement System K3.IAX.4572-13T 2020-01-10 08800017262307 EXULT Knee Replacement System K3.IAX.4572-14T 2020-01-10 08800017262314 EXULT Knee Replacement System K3.IAX.4572-16T 2020-01-10 08800017262321 EXULT Knee Replacement System K3.IAX.4572-18T 2020-01-10 08800017262338 EXULT Knee Replacement System K3.IAX.4775-09T 2020-01-10 08800017262345 EXULT Knee Replacement System K3.IAX.4775-10T 2020-01-10 08800017262352 EXULT Knee Replacement System K3.IAX.4775-11T 2020-01-10 08800017262369 EXULT Knee Replacement System K3.IAX.4775-12T 2020-01-10
Other Devices Sharing Product Codes# 
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