Home GUDID 07640164843292 icotec Anterior Cervical Plate System, Screw Driver, HL 15, 1 Nm
Primary DI 07640164843292
Brand icotec Anterior Cervical Plate System, Screw Driver, HL 15, 1 Nm
Company icotec AG
Model 39-8
Device description icotec Anterior Cervical Plate System, Screw Driver, HL 15, 1 Nm
Published 2021-01-07
Public version status Update
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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07640164843292 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07640164843292 07640164843292 7640164843292
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 480789465 Device count 1 Serial number 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 07640172554227 VADER Pedicle System, Nut Screw, Ti 16-57-41000 16-57-41000 2026-04-30 07640172554234 VADER Pedicle System, Cross-Link, Ti, 30/34 mm 16-57-93034 16-57-93034 2026-04-30 07640172554241 VADER Pedicle System, Cross-Link, Ti, 33/42 mm 16-57-93442 16-57-93442 2026-04-30 07640172554258 VADER Pedicle System, Cross-Link, Ti, 40/53 mm 16-57-94053 16-57-94053 2026-04-30 07640172554265 VADER Pedicle System, Cross-Link, Ti, 50/70 mm 16-57-95070 16-57-95070 2026-04-30 07640172553824 CMORE® System, Torque Wrench, AO-Coupling 45-400H 45-400H 2025-11-24 07640172552872 icotec Systems, Torque-Limiting Adapter, 3.5 Nm 60-035 60-035 2025-03-05 07640172552889 VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm 42-596 42-596 2025-03-05 07640172552902 VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm 42-546-1 42-546-1 2024-11-22 07640172552919 VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm 42-542-1 42-542-1 2024-11-22 07640172552087 VADER Pedicle System, K-wire, Ø 1.1 × 472 mm 42-541 42-541 2023-01-13 07640172552094 VADER Pedicle System, K-wire, Nitinol, Ø 1.1 × 472 mm 42-542 42-542 2023-01-13 07640172552100 VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 × 472 mm 42-546 42-546 2023-01-13 07640164840871 VADER Pedicle System, K-wire, Ø 1.6 x 150 mm 42-545 42-545 2019-07-31 07640164846408 VADER Pedicle System, K-wire, threaded, Ø 1.6 x 472 mm 42-544 42-544 2019-07-31 07640172553916 KONG-TL VBR System, Guiding Sleeve for Locking Screwdriver 44-051 44-051 2026-01-29 07640172552544 CMORE® System, Awl 45-010 45-010 2025-11-24 07640172552551 CMORE® System, Pedicle Probe, Straight 45-020 45-020 2025-11-24 07640172552568 CMORE® System, Drill Guide Sleeve 45-030 45-030 2025-11-24 07640172552575 CMORE® System, Drill Guide Stop 45-030-1 45-030-1 2025-11-24
Other Devices Sharing Product Codes# 
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