Home GUDID 07290014080324 ProMIS™ Fixation System
Primary DI 07290014080324
Brand ProMIS™ Fixation System
Company PREMIA SPINE LTD
Model 86794
Device description Pre-Bent Rod Ø6.0x35mm R128 Hex Edge
Published 2016-03-29
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 MNI Orthosis, Spinal Pedicle Fixation NKB Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
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 07290014080324 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290014080324 07290014080324 7290014080324
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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 649220779 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 true 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 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-09-17 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. NKB 2015-08-05 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 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 NKB 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 NKB 2014-12-08 04546540147769 XIA II Stryker Corporation MNI 2014-12-08 04546540147806 XIA II Stryker Corporation MNI 2014-12-08 04546540147806 XIA II Stryker Corporation NKB 2014-12-08 04546540147806 XIA II Stryker Corporation MNH 2014-12-08 04546540147905 XIA II Stryker Corporation MNH 2014-12-08 04546540147905 XIA II Stryker Corporation NKB 2014-12-08 04546540147905 XIA II Stryker Corporation MNI 2014-12-08 04546540147912 XIA I Stryker Corporation NKB 2014-12-08 04546540147912 XIA I Stryker Corporation MNI 2014-12-08 04546540147912 XIA I Stryker Corporation MNH 2014-12-08