BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    PALATAL BAR

    DI: 00190707055820 · Model: 033-194 · ORTHO ORGANIZERS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PALATAL BAR
    Primary DI
    00190707055820
    Version / Model
    033-194
    Company Name
    ORTHO ORGANIZERS, INC.
    Labeler DUNS
    062165188
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-27
    Public Version
    3
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    33146dd9-6d37-439e-9f20-e34ab759c129
    Distribution End Date
    2023-09-17

    Device Description

    Beta Titanium Reverse Loop Palatal Bar 45mm

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    Yes
    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
    DZC WIRE, ORTHODONTIC

    GMDN Terms

    Code Name
    41397 Orthodontic archwire

    Identifiers

    Type ID
    Primary 00190707055820