Home GUDID 04260148897481 coflex-F™ System 10mm
Primary DI 04260148897481
Brand coflex-F™ System 10mm
Company Paradigm Spine GmbH
Model RPI00010
Published 2015-10-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use 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 04260148897481 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260148897481 04260148897481 4260148897481
GMDN Terms# Term, Definition table Term Definition Lumbar interspinous decompression spacer, sterile A sterile device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.
Regulatory Flags# DUNS number 537619731 Device count 1 Lot or batch true Expiration date on label 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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