BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elite® Bondable Buccal Tubes

    DI: 00190707071042 · Model: 901-122-10 · ORTHO ORGANIZERS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Elite® Bondable Buccal Tubes
    Primary DI
    00190707071042
    Version / Model
    901-122-10
    Company Name
    ORTHO ORGANIZERS, INC.
    Labeler DUNS
    062165188
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-13
    Public Version
    1
    Public Version Date
    2020-07-21
    Public Version Status
    New
    Public Device Record Key
    2da4e205-f98d-4dbb-b3ae-68d7a593c67f

    Device Description

    Elite®.022 L6L STD BRACKET DB

    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
    DZD TUBE, ORTHODONTIC

    GMDN Terms

    Code Name
    31759 Orthodontic tube

    Identifiers

    Type ID
    Primary 00190707071042