Home GUDID 08800043968471 N/A
Primary DI 08800043968471
Brand N/A
Company TDM Co., Ltd.
Model 3305-3611
Catalog number 3305-3611
Device description TLIF Cage: PEEK L36 x W14.51 x A5 x H11
Published 2026-06-10
Public version status New
Distribution status 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 MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800043968471 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800043968471 08800043968471 8800043968471
GMDN Terms# Term, Definition table Term Definition Polymeric 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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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 included with the device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 557801921 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 false 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 00843511102135 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102142 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102159 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102166 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102173 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102180 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102197 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102203 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102210 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102227 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102234 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102241 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102258 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102265 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102272 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102289 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102296 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102302 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102319 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102326 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102333 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102340 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102357 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102364 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102371 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102388 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102395 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102401 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102418 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22 00843511102425 Omnia Medical TiBrid™-TC OMNIA MEDICAL, LLC MAX 2026-07-22