Home GUDID 09348215031497 Cemented TSI Stem System
Primary DI 09348215031497
Brand Cemented TSI Stem System
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 111-34-1002
Published 2019-02-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 09348215031497 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215031497 09348215031497 9348215031497
GMDN Terms# Term, Definition table Term Definition Uncoated femoral stem prosthesis, one-piece A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.
Regulatory Flags# DUNS number 751993028 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 09348215010973 Active-V Knee Cementless CR Femoral Component - Size 1 Narrow - Left 10-1521-0302 2026-05-18 09348215010980 Active-V Knee Cementless CR Femoral Component - Size 1 Narrow - Right 10-1522-0322 2026-05-18 09348215010997 Active-V Knee Cementless CR Femoral Component - Size 1 - Left 10-1521-0303 2026-05-18 09348215011000 Active-V Knee Cementless CR Femoral Component - Size 1 - Right 10-1522-0323 2026-05-18 09348215011017 Active-V Knee Cementless CRFemoral Component - Size 2 Narrow - Left 10-1521-0304 2026-05-18 09348215011024 Active-V Knee Cementless CR Femoral Component - Size 2 Narrow - Right 10-1522-0324 2026-05-18 09348215011031 Active-V Knee Cementless CRFemoral Component - Size 2 - Left 10-1521-0305 2026-05-18 09348215011048 Active-V Knee Cementless CR Femoral Component - Size 2 - Right 10-1522-0325 2026-05-18 09348215011055 Active-V Knee Cementless CRFemoral Component - Size 3 Narrow - Left 10-1521-0306 2026-05-18 09348215011062 Active-V Knee Cementless CR Femoral Component - Size 3 Narrow - Right 10-1522-0326 2026-05-18 09348215011079 Active-V Knee Cementless CRFemoral Component - Size 3 - Left 10-1521-0307 2026-05-18 09348215011086 Active-V Knee Cementless CR Femoral Component - Size 3 - Right 10-1522-0327 2026-05-18 09348215011093 Active-V Knee Cementless CRFemoral Component - Size 4 Narrow - Left 10-1521-0308 2026-05-18 09348215011109 Active-V Knee Cementless CR Femoral Component - Size 4 Narrow - Right 10-1522-0328 2026-05-18 09348215011116 Active-V Knee Cementless CRFemoral Component - Size 4 - Left 10-1521-0309 2026-05-18 09348215011123 Active-V Knee Cementless CR Femoral Component - Size 4 - Right 10-1522-0329 2026-05-18 09348215011130 Active-V Knee Cementless CRFemoral Component - Size 5 Narrow - Left 10-1521-0210 2026-05-18 09348215011147 Active-V Knee Cementless CR Femoral Component - Size 5 Narrow - Right 10-1522-0230 2026-05-18 09348215014506 Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 1 Narrow 10-1513-0400 2026-05-18 09348215014513 Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 1 10-1513-0401 2026-05-18
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