BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    First Molar Single Tubes

    DI: 00192029019535 · Model: 210-397R · TP ORTHODONTICS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    First Molar Single Tubes
    Primary DI
    00192029019535
    Version / Model
    210-397R
    Company Name
    TP ORTHODONTICS INC
    Labeler DUNS
    005432299
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-15
    Public Version
    2
    Public Version Date
    2021-10-29
    Public Version Status
    Update
    Public Device Record Key
    80853c7b-5d91-4d09-8f97-7fdb9baaea2b

    Device Description

    UR 1st Molar Torque 0, Tip 0, Distal Offset 0 0.56 mm 0.71 mm (.022"x .028") 4.0 mm

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ECN CLAMP, WIRE, ORTHODONTIC

    GMDN Terms

    Code Name
    63223 Orthodontic power arm

    Identifiers

    Type ID
    Primary 00192029019535