Home GUDID 00843672101558 INGENIX
Primary DI 00843672101558
Brand INGENIX
Company INGENIUMSPINE, LLC
Model 56010022
Device description Tap for 7.5mm Screw
Published 2018-10-10
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 NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00843672101558 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 00843672101558 00843672101558 843672101558 0843672101558
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 082805471 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 00763000777500 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2026-10-25 00763000777500 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2026-10-25 00763000777623 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2026-10-25 00763000777623 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2026-10-25 00763000786434 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2026-10-25 00763000786434 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2026-10-25 00763000749903 CD HORIZON® Fenestrated Screw Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2026-10-23 00763000750510 CD HORIZON® Fenestrated Screw Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2026-10-23 00763000777616 CD HORIZON® Fenestrated Screw Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2026-10-23 00763000777616 CD HORIZON® Fenestrated Screw Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2026-10-23 03701313009632 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009649 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009656 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009663 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009670 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009687 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009694 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009700 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009717 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009724 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009731 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009748 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009755 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009762 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009779 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009786 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009793 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009809 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313010027 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313010034 KHEIRON S.M.A.I.O NKB 2026-10-23