Home GUDID 00810022403037 LinkBio Instrument
Primary DI 00810022403037
Brand LinkBio Instrument
Company Link Bio Corp
Model 87-1402
Device description Fusion Nail Femoral Trial Right
Published 2023-03-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HWT Template
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWT Template Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810022403037 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810022403037 00810022403037 810022403037 0810022403037
GMDN Terms# Term, Definition table Term Definition Knee stem prosthesis trial A copy of a final femur or tibia stem prosthesis designed to be used during knee arthroplasty (TKA) to determine the correct size of the final prosthesis. It is one of a set, or a set, of graduated sizes and is typically made of metal or polymer material. 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 827608774 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10603295553588 ATTUNE DEPUY ORTHOPAEDICS, INC. HWT 2026-08-26 10603295553595 ATTUNE DEPUY ORTHOPAEDICS, INC. HWT 2026-08-26 10603295553601 ATTUNE DEPUY ORTHOPAEDICS, INC. HWT 2026-08-26 10603295553618 ATTUNE DEPUY ORTHOPAEDICS, INC. HWT 2026-08-26 10705034579900 N/A Medos International Sàrl HWT 2026-08-26 10705034579917 N/A Medos International Sàrl HWT 2026-08-26 10705034579924 N/A Medos International Sàrl HWT 2026-08-26 00889024711464 Comp Mini Humeral Tray Trial Stem Adapter Zimmer, Inc. HWT 2026-08-25 00889024713277 Universal Uni Knee Tensor Zimmer, Inc. HWT 2026-08-25 00889024713284 Right Uni Knee Tensor Zimmer, Inc. HWT 2026-08-25 00889024713291 Left Uni Knee Tensor Zimmer, Inc. HWT 2026-08-25 00860009784925 Flap Marking Template Mirrorme3d, LLC HWT 2023-03-17 00860009784918 Template Mirrorme3d, LLC HWT 2023-02-16 00885556841532 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841549 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841556 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841563 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841570 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841587 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841594 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841600 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841655 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841662 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841679 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841686 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841693 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841709 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841716 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841723 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02 00885556841730 XT Revision Ankle Replacement System Smith & Nephew, Inc. HWT 2023-02-02