BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Patient-Fitted TMJ Reconstructive Prosthesis System

    DI: B004YYMMDDNNNNRF0 · Model: YYMMDDNNNNRF · TMJ Solutions, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Patient-Fitted TMJ Reconstructive Prosthesis System
    Primary DI
    B004YYMMDDNNNNRF0
    Version / Model
    YYMMDDNNNNRF
    Company Name
    TMJ Solutions, Inc.
    Labeler DUNS
    035877922
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-11-10
    Public Version
    1
    Public Version Date
    2021-11-18
    Public Version Status
    New
    Public Device Record Key
    b01caf67-9fd9-4962-80a9-a54805bf0326

    Device Description

    Right Fossa Component

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LZD Joint, Temporomandibular, Implant

    GMDN Terms

    Code Name
    36042 Total temporomandibular joint prosthesis

    Identifiers

    Type ID
    Primary B004YYMMDDNNNNRF0

    Customer Contacts

    Phone
    805-650-3391
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P980052 007