Home GUDID 00840916108106 OMNI
Primary DI 00840916108106
Brand OMNI
Company SPINAL ELEMENTS
Model LCPT 65-K
Device description Keyed Bullet Rod 65mm
Published 2017-06-28
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MNH Orthosis, Spondylolisthesis Spinal Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840916108106 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 00840916108106 00840916108106 840916108106 0840916108106
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 004022104 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 07290115935677 XL Adaptor PREMIA SPINE LTD MNH 2026-10-20 07290115935905 XL Screwdriver CM PREMIA SPINE LTD MNH 2026-10-20 07290115935912 Screwdriver CM PREMIA SPINE LTD MNH 2026-10-20 07290115935929 Tube for K-wire over a k-wire technique 470mm (Nitinol) PREMIA SPINE LTD MNH 2026-10-20 07290115935936 Tube for XL K-Wire 450mm PREMIA SPINE LTD MNH 2026-10-20 07290115935943 Tube for K-Wires of 470mm PREMIA SPINE LTD MNH 2026-10-20 07290115935950 Tube for K-Wires up to 340mm PREMIA SPINE LTD MNH 2026-10-20 07290115932874 Cannulated Screwdriver inner shaft PREMIA SPINE LTD MNH 2026-10-18 07290115932881 Cannulated Screwdriver Handle Assy PREMIA SPINE LTD MNH 2026-10-18 M697X07300251 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X073825100DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382560DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382565DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382570DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382575DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382580DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382585DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382590DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382595DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 08806364689439 Kora Spinal System Medyssey Co., Ltd. MNH 2026-10-01 08806364690077 Kora Spinal System Medyssey Co., Ltd. MNH 2026-10-01 00840916152413 TALON SPINAL ELEMENTS MNH 2020-04-14 00840916152420 TALON SPINAL ELEMENTS MNH 2020-04-14 00840916152437 TALON SPINAL ELEMENTS MNH 2020-04-14 00840916152444 TALON SPINAL ELEMENTS MNH 2020-04-14 00840916152529 TALON SPINAL ELEMENTS MNH 2020-04-14 00840916152536 TALON SPINAL ELEMENTS MNH 2020-04-14 10888857001428 DENALI® MI Spinal System VB Spine LLC MNH 2018-11-05 10888857001435 DENALI® MI Spinal System VB Spine LLC MNH 2018-11-05 10888857001459 DENALI® MI Spinal System VB Spine LLC MNH 2018-11-05