Home GUDID 10705034754635 OPAL
Primary DI 10705034754635
Brand OPAL
Company Synthes GmbH
Model 08.803.216
Catalog number 08803216
Device description OPAL SPACER 10MM X 32MM 16MM HEIGHT
Published 2015-09-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MAX Intervertebral fusion device with bone graft, lumbar MQP SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2 MQP Spinal Vertebral Body Replacement Device Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10705034754635 Primary GS1 0 H981088032160 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10705034754635 10705034754635
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 486711679 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 M719GLL100QC0 3DP Lumbar Interbody System Genesys Orthopedics Systems LLC MAX 2026-07-14 M719GLL101QC0 3DP Lumbar Interbody System Genesys Orthopedics Systems LLC MAX 2026-07-14 M719GLL106QC0 3DP Lumbar Interbody System Genesys Orthopedics Systems LLC MAX 2026-07-14 M719GLL107QC0 3DP Lumbar Interbody System Genesys Orthopedics Systems LLC MAX 2026-07-14 00763000857820 T2 STRATOSPHERE™ Expandable Corpectomy System MEDTRONIC SOFAMOR DANEK, INC. MQP 2026-06-26 00763000858001 T2 STRATOSPHERE™ Expandable Corpectomy System MEDTRONIC SOFAMOR DANEK, INC. MQP 2026-06-26 08800043913099 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913105 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913112 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913129 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913136 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913143 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913150 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913167 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913174 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913181 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913198 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913204 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913211 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917288 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917295 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917301 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917318 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917325 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917332 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917349 N/A TDM Co., Ltd. MAX 2026-06-10 08800043967177 N/A TDM Co., Ltd. MAX 2026-06-10 08800043967184 N/A TDM Co., Ltd. MAX 2026-06-10 08800043967191 N/A TDM Co., Ltd. MAX 2026-06-10 08800043967207 N/A TDM Co., Ltd. MAX 2026-06-10
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