BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ClassOne

    DI: 00190707044992 · Model: 104-47 · ORTHO ORGANIZERS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ClassOne
    Primary DI
    00190707044992
    Version / Model
    104-47
    Company Name
    ORTHO ORGANIZERS, INC.
    Labeler DUNS
    062165188
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-11-21
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    567fbfce-efdb-45f4-8918-3fcb05adb72a

    Device Description

    Rainbow Elastics Heavy 1/4 (6.5oz)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ECI BAND, ELASTIC, ORTHODONTIC

    GMDN Terms

    Code Name
    62074 Orthodontic inter-arch elastic band

    Identifiers

    Type ID
    Primary 00190707044992