Home GUDID 00822409133895 N/A
Primary DI 00822409133895
Brand N/A
Company Ortho Development Corporation
Model C-1862-18
Device description CR Insert Trial with Handle Mating Hole Size 7 18mm
Published 2026-05-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 00822409133895 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 00822409133895 00822409133895 822409133895 0822409133895
GMDN Terms# Term, Definition table Term Definition Knee tibia prosthesis trial, reusable A copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 876542390 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label 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 00888867550292 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550308 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550315 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550322 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550339 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550346 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550353 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550360 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550377 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550384 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552692 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552708 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552715 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552722 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552739 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552746 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552753 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552760 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867574564 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867574571 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867574588 Arthrex® ARTHREX, INC. LXH 2026-09-18 04054896000831 Control Gauges Silony Medical GmbH LXH 2026-09-18 04054896000855 Implant Modifier Silony Medical GmbH LXH 2026-09-18 04054896000862 Implant Modifier Silony Medical GmbH LXH 2026-09-18 04054896000879 Implant Modifier Silony Medical GmbH LXH 2026-09-18 04054896000886 Forceps and Clamps Silony Medical GmbH LXH 2026-09-18 04054896000893 (Re-) Positioning Tools Silony Medical GmbH LXH 2026-09-18 04054896000909 (Re-) Positioning Tools Silony Medical GmbH LXH 2026-09-18 04054896000916 (Re-) Positioning Tools Silony Medical GmbH LXH 2026-09-18 04054896000923 Adapter Silony Medical GmbH LXH 2026-09-18
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