Home GUDID 04260148890314 coflex-F trial, 16mm
Primary DI 04260148890314
Brand coflex-F trial, 16mm
Company Paradigm Spine GmbH
Model RCT00016
Published 2017-06-29
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 KWP Appliance, Fixation, Spinal Interlaminal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04260148890314 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260148890314 04260148890314 4260148890314
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 537619731 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 04260148896927 DSS HP Polyaxial pedicle screw set, Ø5 x 45mm HPI85045 2015-10-01 04260148892516 DSS Nut DPI06011 2015-10-01 04260148892523 DSS Rigid coupler, 20mm DPI70020 2015-10-01 04260148892554 DSS Slotted coupler, 50N/mm stiffness, 26mm long DPI35026 2015-10-01 04260148892561 DSS Slotted coupler, 50N/mm stiffness, 28mm long DPI35028 2015-10-01 04260148892578 DSS Slotted coupler, 50N/mm stiffness, 31mm long DPI35031 2015-10-01 04260148892585 DSS Slotted coupler, 50N/mm stiffness, 35mm long DPI35035 2015-10-01 04260148892592 DSS Rigid coupler, 22-25mm DPI70022 2015-10-01 04260148892608 DSS Rigid coupler, 25-31mm DPI70025 2015-10-01 04260148892615 DSS Rigid coupler, 31-43 mm DPI70031 2015-10-01 04260148892677 DSS Pedicle screw set, Ø5.0 x 30mm DPI45030 2015-10-01 04260148892684 DSS Pedicle screw set, Ø5.0 x 35mm DPI45035 2015-10-01 04260148892691 DSS Pedicle screw set, Ø5.0 x 40mm DPI45040 2015-10-01 04260148892707 DSS Pedicle screw set, Ø5.0 x 45mm DPI45045 2015-10-01 04260148892714 DSS Pedicle screw set, Ø5.0 x 50mm DPI45050 2015-10-01 04260148892721 DSS Pedicle screw set, Ø5.0 x 55mm DPI45055 2015-10-01 04260148892738 DSS Pedicle screw set, Ø5.0 x 60mm DPI45060 2015-10-01 04260148892745 DSS Pedicle screw set, Ø6.0 x 30mm DPI46030 2015-10-01 04260148892752 DSS Pedicle screw set, Ø6.0 x 35mm DPI46035 2015-10-01 04260148892769 DSS Pedicle screw set, Ø6.0 x 40mm DPI46040 2015-10-01
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