Home GUDID 00880304341715 AGC MODULAR TIBIAL II
Primary DI 00880304341715
Brand AGC MODULAR TIBIAL II
Company Biomet Orthopedics, LLC
Model 32-468409
Catalog number 32-468409
Published 2020-05-23
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 HWP PUNCH, FEMORAL NECK
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWP Punch, Femoral Neck Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00880304341715 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 00880304341715 00880304341715 880304341715 0880304341715
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 129278169 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00880304474185 Arcos® Modular Revision Hip System 11-302102 11-302102 2015-10-24 00880304474246 Arcos® Modular Revision Hip System 11-302101 11-302101 2015-10-24 00880304539259 Arcos® Modular Revision Hip System 11-302109 11-302109 2015-10-24 00889024711280 Jgrknt Reusable Fishmouth Perc Guide SSI008662 SSI008662 2026-08-25 00889024712034 Percutaneous Soft Anchor Short 1.4mm Guide SSI008661 SSI008661 2026-08-25 00880304527386 Active Articulation 010000990 010000990 2020-05-15 00880304527393 Active Articulation 010000991 010000991 2020-05-15 00880304485020 Active Articulation Hip System EP-200144 EP-200144 2015-11-03 00880304485037 Active Articulation Hip System EP-200146 EP-200146 2015-11-03 00880304485044 Active Articulation Hip System EP-200148 EP-200148 2015-10-24 00880304485051 Active Articulation Hip System EP-200150 EP-200150 2015-10-24 00880304485068 Active Articulation Hip System EP-200152 EP-200152 2015-10-24 00880304485075 Active Articulation Hip System EP-200154 EP-200154 2015-10-24 00880304485082 Active Articulation Hip System EP-200156 EP-200156 2015-10-24 00880304485099 Active Articulation Hip System EP-200158 EP-200158 2015-10-24 00880304485105 Active Articulation Hip System EP-200160 EP-200160 2015-10-24 00880304485112 Active Articulation Hip System EP-200162 EP-200162 2015-10-24 00880304485129 Active Articulation Hip System EP-200164 EP-200164 2015-11-04 00880304485136 Active Articulation Hip System EP-200166 EP-200166 2015-10-24 00880304491328 Active Articulation™ Dual Mobility Hip System XL-200144 XL-200144 2015-10-24
Other Devices Sharing Product Codes# 
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