BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EdgeOne-R Utopia

    DI: 03701310370360 · Model: Asst L31 Sterile · MICRO MEGA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EdgeOne-R Utopia
    Primary DI
    03701310370360
    Version / Model
    Asst L31 Sterile
    Catalog Number
    EORUA31S
    Company Name
    MICRO MEGA
    Labeler DUNS
    276075371
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-29
    Public Version
    1
    Public Version Date
    2023-10-09
    Public Version Status
    New
    Public Device Record Key
    21a15637-3b04-4009-b285-cc84906da1bd

    Device Description

    Endodontic instrument for professional dental use only

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EKS File, Pulp Canal, Endodontic

    GMDN Terms

    Code Name
    63550 Rotary/reciprocating endodontic file/rasp, single-use

    Identifiers

    Type ID
    Package 23701310370364
    Primary 03701310370360

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep dry
    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight