Home GUDID 04057217001920 NA
Primary DI 04057217001920
Brand NA
Company Z-Medical GmbH + Co. KG
Model A06360_US
Published 2015-06-10
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
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 04057217001920 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04057217001920 04057217001920 4057217001920
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, sterile An assembly of 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. Sterile disposable devices associated with implantation may be included.
Regulatory Flags# DUNS number 332068761 Device count 1 Lot or batch true Expiration date on label 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
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