BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ultra SEP

    DI: D798USEPRK0 · Model: USEPRK · RELIANCE ORTHODONTIC PRODUCTS INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Ultra SEP
    Primary DI
    D798USEPRK0
    Version / Model
    USEPRK
    Company Name
    RELIANCE ORTHODONTIC PRODUCTS INC
    Labeler DUNS
    113170088
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-08
    Public Version
    2
    Public Version Date
    2025-10-09
    Public Version Status
    Update
    Public Device Record Key
    b26a424c-8cff-4190-9a06-b5a56aac48e3

    Device Description

    Ultra SEP Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    PM Exempt
    No
    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

    GMDN Terms

    Code Name
    36153 Dental tooth-etching solution

    Identifiers

    Type ID
    Primary D798USEPRK0