BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Radiopaque Separators

    DI: 00190730006974 · Model: 480-305 · ORTHO TECHNOLOGY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Radiopaque Separators
    Primary DI
    00190730006974
    Version / Model
    480-305
    Company Name
    ORTHO TECHNOLOGY, INC.
    Labeler DUNS
    781772017
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-28
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    264db062-1f74-44e8-8e56-d51e4b42b3da

    Device Description

    Radiopaque Seps Anterior White Loose Separators 1000/pk

    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
    Yes
    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
    42340 Tooth separator

    Identifiers

    Type ID
    Primary 00190730006974