Home GUDID 00840466901646 Primus
Primary DI 00840466901646
Brand Primus
Company SPINAL ELEMENTS, INC.
Model 66023-085-060
Device description 8.5mm x 60mm, Primus DualFix
Published 2026-07-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name KWP Appliance, Fixation, Spinal Interlaminal KWQ Appliance, Fixation, Spinal Intervertebral Body NKB Thoracolumbosacral Pedicle Screw System OLO Orthopedic Stereotaxic Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2 OLO Orthopedic Stereotaxic Instrument Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840466901646 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840466901646 00840466901646 840466901646 0840466901646
GMDN Terms# Term, Definition table Term Definition Spinal bone screw, non-bioabsorbable A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 610712213 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840606168533 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168557 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168571 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168588 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168595 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168601 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168618 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168625 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168632 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168656 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168663 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168687 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168694 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168717 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168748 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168755 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168779 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168786 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168809 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168816 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168830 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168847 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168861 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168878 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168892 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168908 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168922 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168939 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606169769 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606169776 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27
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