Home GUDID 07640178973862 ROMEO 2 INSTRUMENTATION
Primary DI 07640178973862
Brand ROMEO 2 INSTRUMENTATION
Company SpineArt SA
Model ELL-IN 04 10-N
Catalog number ELL-IN 04 10-N
Device description SETSCREW HOLDER
Published 2018-12-18
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 07640178973862 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07640178973862 07640178973862 7640178973862
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant/trial-implant/sizer holder, reusable A hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft), trial implant, or sizer (e.g., glenoid defect sizer) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during an orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 483016148 Device count 1 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 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-09-17 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-09-17 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 04546540147257 XIA II Stryker Corporation MNI 2014-12-08 04546540147257 XIA II Stryker Corporation MNH 2014-12-08 04546540147769 XIA II Stryker Corporation MNH 2014-12-08 04546540147769 XIA II Stryker Corporation MNI 2014-12-08 04546540147806 XIA II Stryker Corporation MNH 2014-12-08 04546540147806 XIA II Stryker Corporation MNI 2014-12-08 04546540147905 XIA II Stryker Corporation MNH 2014-12-08 04546540147905 XIA II Stryker Corporation MNI 2014-12-08 04546540147912 XIA I Stryker Corporation MNI 2014-12-08 04546540147912 XIA I Stryker Corporation MNH 2014-12-08 04546540147929 XIA I Stryker Corporation MNH 2014-12-08 04546540147929 XIA I Stryker Corporation MNI 2014-12-08 04546540147936 XIA I Stryker Corporation MNH 2014-12-08 04546540147936 XIA I Stryker Corporation MNI 2014-12-08 04546540147974 XIA I Stryker Corporation MNH 2014-12-08 04546540147974 XIA I Stryker Corporation MNI 2014-12-08 04546540147981 XIA I Stryker Corporation MNI 2014-12-08 04546540147981 XIA I Stryker Corporation MNH 2014-12-08 04546540147998 XIA I Stryker Corporation MNI 2014-12-08 04546540147998 XIA I Stryker Corporation MNH 2014-12-08