Home GUDID 09348215072643
Trial BiPolar Head 22-39
Primary DI 09348215072643
Brand Trial BiPolar Head 22-39
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 112-24-0139
Published 2020-06-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 09348215072643 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215072643 09348215072643 9348215072643
GMDN Terms# Term, Definition table Term Definition Surgical implant template, reusable A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 751993028 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 false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use 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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