Home GUDID 08800113938656
Rexious
Primary DI 08800113938656
Brand Rexious
Company DIOMEDICAL CO.,LTD.
Model A
Catalog number BT.MS.100035
Device description Mono-Axial Pedicle E Type (Single & Self Tapping) (L1)53x(L2)35x(A)10x(B)13.5mm-Ø6.0
Published 2021-05-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Single use true
Product Codes# Code, Name table Code Name MNH Orthosis, spondylolisthesis spinal fixation MNI Orthosis, spinal pedicle fixation NKB Thoracolumbosacral pedicle screw system
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 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800113938656 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800113938656 08800113938656 8800113938656
GMDN Terms# Term, Definition table Term Definition Spinal fixation plate, non-bioabsorbable A small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 557795909 Device count 1 DM exempt true Lot or batch true Manufacturing date on label 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 07290115932508 Tower Guide ST PREMIA SPINE LTD MNI 2026-07-23 07290115932508 Tower Guide ST PREMIA SPINE LTD MNH 2026-07-23 07290115932508 Tower Guide ST PREMIA SPINE LTD NKB 2026-07-23 M719GL201TL0 SIros-X Genesys Orthopedics Systems LLC NKB 2026-07-23 00840019935319 Reform Ti PRECISION SPINE, INC. NKB 2019-10-07 00840019935364 Reform Ti PRECISION SPINE, INC. NKB 2019-10-07 00840019934800 Reform Ti PRECISION SPINE, INC. NKB 2019-10-04 00840019934817 Reform Ti PRECISION SPINE, INC. NKB 2019-10-04 00840019934824 Reform Ti PRECISION SPINE, INC. NKB 2019-10-04 00840019934831 Reform Ti PRECISION SPINE, INC. NKB 2019-10-04 00840019934725 Reform Ti PRECISION SPINE, INC. NKB 2019-09-25 00840019934732 Reform Ti PRECISION SPINE, INC. NKB 2019-09-25 00840019934749 Reform Ti PRECISION SPINE, INC. NKB 2019-09-25 00840019934756 Reform Ti PRECISION SPINE, INC. NKB 2019-09-25 00840019934763 Reform Ti PRECISION SPINE, INC. NKB 2019-09-25 00840019934770 Reform Ti PRECISION SPINE, INC. NKB 2019-09-25 00840019934787 Reform Ti PRECISION SPINE, INC. NKB 2019-09-25 00840019934794 Reform Ti PRECISION SPINE, INC. NKB 2019-09-25 00840019934251 Reform Ti PRECISION SPINE, INC. NKB 2019-09-10 00840019934268 Reform Ti PRECISION SPINE, INC. NKB 2019-09-10 00840019934275 Reform Ti PRECISION SPINE, INC. NKB 2019-09-10 00840019934282 Reform Ti PRECISION SPINE, INC. NKB 2019-09-10 00840019934299 Reform Ti PRECISION SPINE, INC. NKB 2019-09-10 00840019934305 Reform TI PRECISION SPINE, INC. NKB 2019-09-10 00840019934312 Reform Ti PRECISION SPINE, INC. NKB 2019-09-10 00840019934329 Reform Ti PRECISION SPINE, INC. NKB 2019-09-10 00840019934336 Reform Ti PRECISION SPINE, INC. NKB 2019-09-10 00840019934343 Reform Ti PRECISION SPINE, INC. NKB 2019-09-10 00840019934350 Reform Ti PRECISION SPINE, INC. NKB 2019-09-10 00840019934367 Reform TI PRECISION SPINE, INC. NKB 2019-09-10