Home GUDID 08800313887457 4CIS® Spinal System and 4CIS® Low Back System
Primary DI 08800313887457
Brand 4CIS® Spinal System and 4CIS® Low Back System
Company ALPHA AI CO.,LTD.
Model 4152-7030
Catalog number 4152-7030
Device description Poly-Axial Pedicle Screw for 5.7 Rod with the head dimension fixed at 11.5x24
Published 2026-04-15
Public version status New
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 MNH Orthosis, Spondylolisthesis Spinal Fixation MNI Orthosis, Spinal Pedicle Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800313887457 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800313887457 08800313887457 8800313887457
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 687844241 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 08800377762103 Spinal Fusion Cage System DPUC-40J8 DPUC-40J8 2024-02-22 08800377762127 Spinal Fusion Cage System DPUC-40JA DPUC-40JA 2024-02-22 08800377762141 Spinal Fusion Cage System DPUC-40JC DPUC-40JC 2024-02-22 08800377762165 Spinal Fusion Cage System DPUC-40JE DPUC-40JE 2024-02-22 08800377762363 Spinal Fusion Cage System DPUC-45J8 DPUC-45J8 2024-02-22 08800377762387 Spinal Fusion Cage System DPUC-45JA DPUC-45JA 2024-02-22 08800377762400 Spinal Fusion Cage System DPUC-45JC DPUC-45JC 2024-02-22 08800377762424 Spinal Fusion Cage System DPUC-45JE DPUC-45JE 2024-02-22 08800377762622 Spinal Fusion Cage System DPUC-50J8 DPUC-50J8 2024-02-22 08800377762646 Spinal Fusion Cage System DPUC-50JA DPUC-50JA 2024-02-22 08800377762660 Spinal Fusion Cage System DPUC-50JC DPUC-50JC 2024-02-22 08800377762684 Spinal Fusion Cage System DPUC-50JE DPUC-50JE 2024-02-22 08800377762882 Spinal Fusion Cage System DPUC-55J8 DPUC-55J8 2024-02-22 08800377762905 Spinal Fusion Cage System DPUC-55JA DPUC-55JA 2024-02-22 08800377762929 Spinal Fusion Cage System DPUC-55JC DPUC-55JC 2024-02-22 08800377762943 Spinal Fusion Cage System DPUC-55JE DPUC-55JE 2024-02-22 08800313887983 SOLCO 4CIS® General Plate System 96-50810 96-50810 2026-04-21 08800313887044 4CIS® Spinal System and 4CIS® Low Back System 62-45045 62-45045 2026-04-15 08800313887051 4CIS® Spinal System and 4CIS® Low Back System 62-55050 62-55050 2026-04-15 08800313887068 4CIS® Spinal System and 4CIS® Low Back System 62-65030 62-65030 2026-04-15
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