Home GUDID 00840402511441
PCT
Primary DI 00840402511441
Brand PCT
Company Silony Medical Corp
Model PCT0435060
Catalog number PCT0435060
Device description 3.5mm Pre-Lordosed Rod,60mm
Published 2025-11-24
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 NKG Posterior cervical screw system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 NKG Posterior Cervical Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815101027203 Previous GS1 0 00840402511441 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 00815101027203 00815101027203 815101027203 0815101027203 00840402511441 00840402511441 840402511441 0840402511441
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system rod An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 106081213 Device count 1 Lot or batch true 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 00840466901035 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901172 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901479 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901486 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901493 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901509 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901516 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901523 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901530 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901547 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901554 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901561 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901578 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901585 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901592 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901608 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901615 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901622 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21