Home GUDID 00840916123130 ZEUS-P
Primary DI 00840916123130
Brand ZEUS-P
Company SPINAL ELEMENTS
Model 65-260914
Device description Zeus-P Implant 14 x 9 x 26mm
Published 2017-08-06
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name FDA Enteroscope And Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDA Enteroscope And Accessories Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840916123130 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 00840916123130 00840916123130 840916123130 0840916123130
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 004022104 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 00860014745003 FUJIFILM Stiffening Wire (SW-2000) Fujifilm Healthcare Americas Corporation FDA 2025-12-18 04547410491715 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 04547410514056 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 14547410491712 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 14547410514053 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 10197106523643 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2024-01-24 50197106523641 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2024-01-24 10197106447185 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2023-11-09 50197106447183 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2023-11-09 10860006600805 Ancora Aspero Medical, Inc. FDA 2023-10-26 00847627004703 CD138 + Cyclin D1 BIOCARE MEDICAL LLC FDA 2023-06-21 04547410467284 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 04547410324280 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 04547410467260 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 14547410467281 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 04547410463439 FUJIFILM FUJIFILM CORPORATION FDA 2022-01-30 04953170165801 HANGER ADAPTER SET OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-17 04953170165825 PROBE ARM SET A OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-17 04953170165849 PROBE ARM SET B OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-17 04953170165740 STOPPER OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-16 04953170165757 WATER RESISTANT CAP OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-16 04953170165764 PROBE HANGER OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-16 06934955960246 Jade PTA Balloon Dilatation Catheter OrbusNeich Medical (ShenZhen) Co., Ltd. FDA 2020-12-25 00052569143735 HealthMart STRATEGIC SOURCING SERVICES LLC FDA 2020-07-31 10052569143732 HealthMart MCKESSON CORPORATION FDA 2020-07-31 00075289122811 ProWorks TRANZONIC COMPANIES, THE FDA 2020-04-02 70075289122810 ProWorks TRANZONIC COMPANIES, THE FDA 2020-04-02 04547410384536 FUJIFILM FUJIFILM CORPORATION FDA 2019-07-04 00811503033316 Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATION FDA 2019-03-27 10811503033306 Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATION FDA 2019-03-27