BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Band Assemblies

    DI: 00190707084516 · Model: 087E · ORTHO ORGANIZERS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Band Assemblies
    Primary DI
    00190707084516
    Version / Model
    087E
    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
    0d729c08-7639-4431-88b0-5f1276f02353

    Device Description

    Tempra Etch First Molar Band / Sheath - Hook

    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
    ECM BAND, PREFORMED, ORTHODONTIC

    GMDN Terms

    Code Name
    38734 Orthodontic metal band

    Identifiers

    Type ID
    Primary 00190707084516