BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sunshine Diamonds

    DI: ESUNF3725LW8 · Model: F3725LW · Dr. Hopf GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Sunshine Diamonds
    Primary DI
    ESUNF3725LW8
    Version / Model
    F3725LW
    Company Name
    Dr. Hopf GmbH & Co. KG
    Labeler DUNS
    322126798
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2023-06-30
    Public Version
    1
    Public Version Date
    2023-07-10
    Public Version Status
    New
    Public Device Record Key
    69b1100b-e78e-4685-99aa-e084d614eac0

    Device Description

    Separating strips

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EHM Strip, Polishing Agent

    GMDN Terms

    Code Name
    35702 Dental abrasive strip, single-use

    Identifiers

    Type ID
    Unit of Use ESUNF3725LW1
    Primary ESUNF3725LW8