Home GUDID 04047844005347 MONOPOLY
Primary DI 04047844005347
Brand MONOPOLY
Company SIGNUS Medizintechnik GmbH
Model Pedicle screw, reduction, polyaxial
Catalog number MP0160-4555
Device description The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti-6AL-4V-Eli).
Published 2014-08-31
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 KWP Appliance, Fixation, Spinal Interlaminal MNH Orthosis, Spondylolisthesis Spinal Fixation MNI Orthosis, Spinal Pedicle Fixation NKB Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 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 04047844005347 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04047844005347 04047844005347 4047844005347
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 Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 35 Degrees Celsius
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 344203948 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 04047844129241 DIPLOMAT Threaded awl cannulated, obturator AC0088 2026-05-20 04047844129258 DIPLOMAT Threaded awl cannulated, obturator AC0089 2026-05-20 04047844102596 COSY Cross connector CA0155-38048/S 2023-03-21 04047844102602 COSY Cross connector CA0155-44052/S 2023-03-21 04047844098479 COSY Retaining nut tulips cross connector CA0160-00200 2023-03-15 04047844127063 COSY Tray, lid CB03AY-LID-1 2026-04-22 04047844098707 COSY Occiput plate CA0005-32056 2023-03-15 04047844116432 COSY Obturatorwire CB0101-3 2023-03-15 04047844116449 COSY Guide wire, round/round CB0144 2023-03-15 04047844129272 INSTRUMENT Tray, instruments P009AY 2026-02-11 04047844129289 INSTRUMENT Tray, insert, instruments P009AZ 2026-02-11 04047844129296 COSY Tray, implants CA01AY 2026-02-11 04047844129302 COSY Tray, insert, implants CA01AZ 2026-02-11 04047844129319 COSY Tray, implants CA02AY 2026-02-11 04047844129326 COSY Rack, screws CA1235AZ 2026-02-11 04047844129333 COSY Rack, screws CA1240AZ 2026-02-11 04047844129340 COSY Rack, screws CA1245AZ 2026-02-11 04047844129357 COSY Rack, shank screws CA1735AZ 2026-02-11 04047844129364 COSY Rack, shank screws CA1740AZ 2026-02-11 04047844129371 COSY Rack, screws angled CA3235AZ 2026-02-11
Other Devices Sharing Product Codes# 
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