BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SmileGoods Right-Bite Aligner Seaters

    DI: 00723896021910 · Model: 71098113 · PRACTICON, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SmileGoods Right-Bite Aligner Seaters
    Primary DI
    00723896021910
    Version / Model
    71098113
    Catalog Number
    71098113
    Company Name
    PRACTICON, INC.
    Labeler DUNS
    119193803
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-07
    Public Version
    2
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    8d77aec2-7da0-4407-a3fd-bc3ab9331a9d

    Device Description

    Plastic seat with three appendages for different areas of arch. Assortment of colors, 24 pack

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ECQ Aligner, Bracket, Orthodontic

    GMDN Terms

    Code Name
    63676 Orthodontic aligner/retainer seater, single-use

    Identifiers

    Type ID
    Package 00723896021927
    Primary 00723896021910