Home GUDID 25002204 GUARDIAN®
Primary DI 25002204
Brand GUARDIAN®
Company Microport Orthopedics Inc.
Model 25002204
Catalog number 25002204
Device description GUARDIAN® TIBIAL SLEEVE SIZE 4
Published 2015-10-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 25002204 Direct Marking HIBCC 0 M684250022041 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Uncoated knee tibia prosthesis, metallic An implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and/or the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.
Regulatory Flags# DUNS number 079118736 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 true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07611996074901 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074918 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074925 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074956 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074963 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074970 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074987 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996075007 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996075021 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996075038 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996095609 SLR-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996095616 SLR-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996095623 SLR-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996095654 SLR-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996095661 SLR-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996095685 SLR-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996013788 SL-PLUS Smith & Nephew, Inc. JDI 2015-11-25 07611996013795 SL-PLUS Smith & Nephew, Inc. JDI 2015-11-25 07611996013849 SL-PLUS Smith & Nephew, Inc. JDI 2015-11-25 07611996014990 BOFOR/EP-FIT PLUS/PROMOS/MPF Smith & Nephew, Inc. JDI 2015-11-25 07611996045208 MODULAR-PLUS Smith & Nephew, Inc. JDI 2015-11-25 07611996065343 SL-PLUS Smith & Nephew, Inc. JDI 2015-11-25 07611996076394 SL-PLUS Smith & Nephew, Inc. JDI 2015-11-25 07611996081008 SL-PLUS Smith & Nephew, Inc. JDI 2015-11-25 07611996081022 SL-PLUS Smith & Nephew, Inc. JDI 2015-11-25 07611996081046 SL-PLUS Smith & Nephew, Inc. JDI 2015-11-25 07611996081077 SL-PLUS Smith & Nephew, Inc. JDI 2015-11-25 07611996081084 SL-PLUS Smith & Nephew, Inc. JDI 2015-11-25 07611996081091 SL-PLUS Smith & Nephew, Inc. JDI 2015-11-25 07611996081107 SL-PLUS Smith & Nephew, Inc. JDI 2015-11-25
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