BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dilatan Plus

    DI: 08033638800355 · Model: Dilators 23/27 mm diameter · SAPI MED SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Dilatan Plus
    Primary DI
    08033638800355
    Version / Model
    Dilators 23/27 mm diameter
    Catalog Number
    A.1002
    Company Name
    SAPI MED SPA
    Labeler DUNS
    437320088
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-27
    Public Version
    1
    Public Version Date
    2023-08-04
    Public Version Status
    New
    Public Device Record Key
    58b73fe1-bdc2-4c4a-9c64-8b52ada002eb

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    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
    FFP Dilator, Rectal

    GMDN Terms

    Code Name
    11262 Rectal dilator, reusable

    Identifiers

    Type ID
    Package 08033638803943
    Primary 08033638800355