BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EVA SELECT

    DI: D83399924121050 · Model: 9992412105 · ImageWorks
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EVA SELECT
    Primary DI
    D83399924121050
    Version / Model
    9992412105
    Catalog Number
    9992412105
    Company Name
    ImageWorks
    Labeler DUNS
    833648087
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-02
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    6d64e4d4-b874-48df-9f18-26b3bf5ddf93

    Device Description

    EVA SELECT SIZE 1 SENSOR

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MUH System,X-Ray,Extraoral Source,Digital

    GMDN Terms

    Code Name
    40876 General-purpose dental x-ray system application software

    Identifiers

    Type ID
    Primary D83399924121050

    Premarket Submissions

    Submission Number Supplement Number
    K123419 000