Home GUDID 00643169636187 N/A
Primary DI 00643169636187
Brand N/A
Company MEDTRONIC NAVIGATION, INC.
Model 9734954
Device description TRIAL KIT 9734954 CLYDESDALE 10X45 MM
Published 2018-12-09
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 MAX Intervertebral fusion device with bone graft, lumbar OLO Orthopedic stereotaxic instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2 OLO Orthopedic Stereotaxic Instrument Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00643169636187 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 00643169636187 00643169636187 643169636187 0643169636187
GMDN Terms# Term, Definition table Term Definition Spinal implant trial A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 835233107 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 00197157075859 ZAVATION INSERTER Zavation LLC MAX 2026-05-27 00810166522366 X-PAC EXPANDING INNOVATIONS, INC. MAX 2026-05-27 00810166522373 X-PAC EXPANDING INNOVATIONS, INC. MAX 2026-05-27 10885862656117 Newton Exactech, Inc. OLO 2026-05-27 10885862656124 Newton Exactech, Inc. OLO 2026-05-27 10885862656131 Newton Exactech, Inc. OLO 2026-05-27 10885862656148 Newton Exactech, Inc. OLO 2026-05-27 10885862656155 Newton Exactech, Inc. OLO 2026-05-27 10885862656162 Newton Exactech, Inc. OLO 2026-05-27 10885862656179 Newton Exactech, Inc. OLO 2026-05-27 B70712535005S0 Dual X Graft Tamp Short AMPLIFY SURGICAL, INC. MAX 2026-05-27 B707129410010130 DUALXS T/PLIF 15 DEG x 9-12MM AMPLIFY SURGICAL, INC. MAX 2026-05-27 B707129410010200 DUALXS T/PLIF 18 DEG x 10-13MM AMPLIFY SURGICAL, INC. MAX 2026-05-27 07613153100263 NA STRYKER CORPORATION OLO 2016-09-23 07613154028177 NA STRYKER CORPORATION OLO 2016-09-23 07613153045250 NA Stryker Leibinger GmbH & Co. KG OLO 2016-08-24 07613153046196 AVS PL Stryker Corporation MAX 2015-09-14 07613153046202 AVS PL Stryker Corporation MAX 2015-09-14 07613153046219 AVS PL Stryker Corporation MAX 2015-09-14 07613153046233 AVS PL Stryker Corporation MAX 2015-09-14 07613153046301 AVS PL Stryker Corporation MAX 2015-09-14 07613153046325 AVS PL Stryker Corporation MAX 2015-09-14 07613153046332 AVS PL Stryker Corporation MAX 2015-09-14 07613153046356 AVS PL Stryker Corporation MAX 2015-09-14 07613153046363 AVS PL Stryker Corporation MAX 2015-09-14 07613153046394 AVS TL Stryker Corporation MAX 2015-09-14 07613153046400 AVS TL Stryker Corporation MAX 2015-09-14 07613153046417 AVS TL Stryker Corporation MAX 2015-09-14 07613153046424 AVS TL Stryker Corporation MAX 2015-09-14 07613153046431 AVS TL Stryker Corporation MAX 2015-09-14
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