Home GUDID 09348215041595 Tibial Tower
Primary DI 09348215041595
Brand Tibial Tower
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 122-10-0170
Published 2018-10-09
Public version status Update
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 MDM Instrument, Manual, Surgical, General Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09348215041595 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215041595 09348215041595 9348215041595
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning 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 [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810220800171 Adler Instrument Company Adler, Inc. MDM 2026-05-26 00810220800188 Adler Instrument Company Adler, Inc. MDM 2026-05-26 06438394002678 Activa Instrument Bioretec Oy MDM 2026-03-23 06438394002685 Activa Instrument Bioretec Oy MDM 2026-03-23 06438394002692 Activa Instrument Bioretec Oy MDM 2026-03-23 06438394020382 Activa Instrument Bioretec Oy MDM 2026-03-23 06438394010956 Activa Instrument Bioretec Oy MDM 2026-03-23 00198506089619 ELMED INCORPORATED ELMED INCORPORATED MDM 2026-03-17 00888867519459 Arthrex® ARTHREX, INC. MDM 2026-03-16 00888867519473 Arthrex® ARTHREX, INC. MDM 2026-03-16 00888867519503 Arthrex® ARTHREX, INC. MDM 2026-03-16 00888867519510 Arthrex® ARTHREX, INC. MDM 2026-03-16 00888867529755 Arthrex® ARTHREX, INC. MDM 2026-03-16 00888867529793 Arthrex® ARTHREX, INC. MDM 2026-03-16 00888867529823 Arthrex® ARTHREX, INC. MDM 2026-03-16 00198506089510 ELMED INCORPORATED ELMED INCORPORATED MDM 2026-03-13 00810158219236 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219243 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219250 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219281 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219304 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219311 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219359 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219373 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219007 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-11 00810158219014 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-11 00810158219021 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-11 00810158219038 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-11 00810158219069 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-11 00810158219090 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-11