BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Planmed

    DI: 06430035430055 · Model: Sophie Classic · Planmed Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Planmed
    Primary DI
    06430035430055
    Version / Model
    Sophie Classic
    Company Name
    Planmed Oy
    Labeler DUNS
    459718193
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-07
    Public Version
    4
    Public Version Date
    2023-06-14
    Public Version Status
    Update
    Public Device Record Key
    1ae19494-ceb5-4673-a73b-b74f694f6379
    Distribution End Date
    2020-04-17

    Device Description

    Planmed Sophie Classic is a mammographic x-ray unit intended for diagnosis of breast cancer.

    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
    IZH System, X-Ray, Mammographic

    GMDN Terms

    Code Name
    37630 Stationary mammographic x-ray system, analogue

    Identifiers

    Type ID
    Primary 06430035430055