Home GUDID 00193982141097 HEDRON
Primary DI 00193982141097
Brand HEDRON
Company GLOBUS MEDICAL, INC.
Model 1208.0109S
Catalog number 1208.0109S
Device description HEDRON A Spacer, 22x29, 9mm, 8°
Published 2026-08-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MAX Intervertebral fusion device with bone graft, lumbar PHM Intervertebral fusion device with bone graft, thoracic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2 PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00193982141097 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 00193982141097 00193982141097 193982141097 0193982141097
GMDN Terms# Term, Definition table Term Definition Metallic spinal interbody fusion cage A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.
Device Sizes# Type, Value, Unit table Type Value Unit Angle 0 Depth 0 Height 0 Width 0
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 139105691 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 false 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 00843511102852 Omnia Medical TiBrid™-TS OMNIA MEDICAL, LLC MAX 2026-08-18 00843511102869 Omnia Medical TiBrid™-TS OMNIA MEDICAL, LLC MAX 2026-08-18 00843511102876 Omnia Medical TiBrid™-TS OMNIA MEDICAL, LLC MAX 2026-08-18 00843511102883 Omnia Medical TiBrid™-TS OMNIA MEDICAL, LLC MAX 2026-08-18 00843511102890 Omnia Medical TiBrid™-TS OMNIA MEDICAL, LLC MAX 2026-08-18 00843511102906 Omnia Medical TiBrid™-TS OMNIA MEDICAL, LLC MAX 2026-08-18 00843511102913 Omnia Medical TiBrid™-TS OMNIA MEDICAL, LLC MAX 2026-08-18 00843511102920 Omnia Medical TiBrid™-TS OMNIA MEDICAL, LLC MAX 2026-08-18 00193982141103 HEDRON GLOBUS MEDICAL, INC. PHM 2026-08-14 00193982141103 HEDRON GLOBUS MEDICAL, INC. MAX 2026-08-14 00193982141110 HEDRON GLOBUS MEDICAL, INC. PHM 2026-08-14 00193982141110 HEDRON GLOBUS MEDICAL, INC. MAX 2026-08-14 00193982141127 HEDRON GLOBUS MEDICAL, INC. PHM 2026-08-14 00193982141127 HEDRON GLOBUS MEDICAL, INC. MAX 2026-08-14 00193982141134 HEDRON GLOBUS MEDICAL, INC. PHM 2026-08-14 00193982141134 HEDRON GLOBUS MEDICAL, INC. MAX 2026-08-14 00193982141141 HEDRON GLOBUS MEDICAL, INC. MAX 2026-08-14 00193982141141 HEDRON GLOBUS MEDICAL, INC. PHM 2026-08-14 00193982141158 HEDRON GLOBUS MEDICAL, INC. MAX 2026-08-14 00193982141158 HEDRON GLOBUS MEDICAL, INC. PHM 2026-08-14 00193982141165 HEDRON GLOBUS MEDICAL, INC. PHM 2026-08-14 00193982141165 HEDRON GLOBUS MEDICAL, INC. MAX 2026-08-14 00193982141172 HEDRON GLOBUS MEDICAL, INC. MAX 2026-08-14 00193982141172 HEDRON GLOBUS MEDICAL, INC. PHM 2026-08-14 00193982141189 HEDRON GLOBUS MEDICAL, INC. MAX 2026-08-14 00193982141189 HEDRON GLOBUS MEDICAL, INC. PHM 2026-08-14 00193982141196 HEDRON GLOBUS MEDICAL, INC. PHM 2026-08-14 00193982141196 HEDRON GLOBUS MEDICAL, INC. MAX 2026-08-14 00193982141202 HEDRON GLOBUS MEDICAL, INC. PHM 2026-08-14 00193982141202 HEDRON GLOBUS MEDICAL, INC. MAX 2026-08-14
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