Home GUDID 07613327626605 Patient-Fitted TMJ Reconstructive Prosthesis System
Primary DI 07613327626605
Brand Patient-Fitted TMJ Reconstructive Prosthesis System
Company TMJ Solutions, Inc.
Model CHG024
Device description TMJ Unilateral Implant, oversized
Published 2023-09-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name LZD Joint, Temporomandibular, Implant
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LZD Joint, Temporomandibular, Implant Dental 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07613327626605 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07613327626605 07613327626605 7613327626605
GMDN Terms# Term, Definition table Term Definition Total temporomandibular joint prosthesis A sterile artificial substitute for the temporomandibular joint (TMJ) implanted to treat patients with osteoarthritis, rheumatoid arthritis, congenital malformations, or neoplasms of the joint, as well as after trauma (e.g., fracture). It consists of mandibular condyle and mandibular fossa components implanted to functionally reconstruct the TMJ in the jaw. It is typically made of metal and/or polymeric materials. Fixation devices for implantation (e.g., screws) may be included.
Regulatory Flags# DUNS number 035877922 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 true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07613327626551 Patient-Fitted TMJ Reconstructive Prosthesis System CHG010 2023-09-11 07613327626568 Patient-Fitted TMJ Reconstructive Prosthesis System CHG026 2023-09-11 07613327626575 Patient-Fitted TMJ Reconstructive Prosthesis System CHG020 2023-09-11 07613327626650 Patient-Fitted TMJ Reconstructive Prosthesis System 61-2006 2023-09-11 07613327626674 Patient-Fitted TMJ Reconstructive Prosthesis System 61-2012 2023-09-11 07613327626681 Patient-Fitted TMJ Reconstructive Prosthesis System 65-2005 2023-09-11 07613327626698 Patient-Fitted TMJ Reconstructive Prosthesis System 61-2008 2023-09-11 07613327626704 Patient-Fitted TMJ Reconstructive Prosthesis System 61-2016 2023-09-11 07613327626711 Patient-Fitted TMJ Reconstructive Prosthesis System 65-2006 2023-09-11 07613327626728 Patient-Fitted TMJ Reconstructive Prosthesis System 65-2008 2023-09-11 07613327626742 Patient-Fitted TMJ Reconstructive Prosthesis System 61-2010 2023-09-11 07613327626759 Patient-Fitted TMJ Reconstructive Prosthesis System 65-2016 2023-09-11 07613327626766 Patient-Fitted TMJ Reconstructive Prosthesis System 65-2012 2023-09-11 07613327626773 Patient-Fitted TMJ Reconstructive Prosthesis System 61-2005 2023-09-11 07613327626780 Patient-Fitted TMJ Reconstructive Prosthesis System 65-2014 2023-09-11 07613327626797 Patient-Fitted TMJ Reconstructive Prosthesis System 65-2010 2023-09-11 07613327626803 Patient-Fitted TMJ Reconstructive Prosthesis System 61-2310 2023-09-11 07613327626810 Patient-Fitted TMJ Reconstructive Prosthesis System 61-2314 2023-09-11 07613327626827 Patient-Fitted TMJ Reconstructive Prosthesis System 61-2308 2023-09-11 07613327626834 Patient-Fitted TMJ Reconstructive Prosthesis System 61-2316 2023-09-11
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07613327626551 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626568 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626575 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626650 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626674 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626681 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626698 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626704 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626711 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626728 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626742 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626759 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626766 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626773 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626780 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626797 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626803 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626810 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626827 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626834 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626841 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626858 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626865 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626872 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626889 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626896 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626902 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626919 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327626926 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11 07613327627763 Patient-Fitted TMJ Reconstructive Prosthesis System TMJ Solutions, Inc. LZD 2023-09-11