Home GUDID 00880304456754 VERSA-DIAL(TM) SHOULDER SYSTEM
Primary DI 00880304456754
Brand VERSA-DIAL(TM) SHOULDER SYSTEM
Company Biomet Orthopedics, LLC
Model 407268
Catalog number 407268
Published 2017-07-28
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 HSD PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED KWS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED MBF PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic 2 KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic 2 KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic 2 MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00880304456754 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 00880304456754 00880304456754 880304456754 0880304456754
GMDN Terms# Term, Definition table Term Definition Humeral head prosthesis trial, reusable A copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is typically made of metal and/or polymer. 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 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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