Home GUDID 09348215017293 Signature BiPolar Head
Primary DI 09348215017293
Brand Signature BiPolar Head
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 111-21-2842
Published 2018-04-30
Public version status Update
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 KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09348215017293 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215017293 09348215017293 9348215017293
GMDN Terms# Term, Definition table Term Definition Bipolar femoral head outer component, hemiarthroplasty An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.
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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