BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MEDRAD® TMJ Positioning Device and Mouthpeices

    DI: 00616258009315 · Model: TMJ 250 · BAYER MEDICAL CARE INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MEDRAD® TMJ Positioning Device and Mouthpeices
    Primary DI
    00616258009315
    Version / Model
    TMJ 250
    Catalog Number
    TMJ 250
    Company Name
    BAYER MEDICAL CARE INC.
    Labeler DUNS
    058716649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-22
    Public Version
    4
    Public Version Date
    2020-06-05
    Public Version Status
    Update
    Public Device Record Key
    38ac0f09-aa36-4fc1-a8fc-549c0bfa9895

    Device Description

    " TMJ Device Disposable Mouth Pieces (MOUTHPIECES,REPLACEMENT,TMJ,MC) (85104470)"

    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
    No
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EAG Cephalometer

    GMDN Terms

    Code Name
    35700 Facebow

    Identifiers

    Type ID
    Package 10616258009312
    Primary 00616258009315

    Customer Contacts

    Phone
    +1(800)633-7231
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K870243 000