Home GUDID 09348215067250 Shaver 11mm
Primary DI 09348215067250
Brand Shaver 11mm
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 132-072-017
Published 2020-07-01
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 LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09348215067250 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215067250 09348215067250 9348215067250
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. 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 751993028 Device count 1 DM exempt false Premarket exempt true 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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