BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ORTHOPANTOMOGRAPH OP 2D

    DI: 06430035872701 · Model: OP30-2 · PaloDEx Group Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ORTHOPANTOMOGRAPH OP 2D
    Primary DI
    06430035872701
    Version / Model
    OP30-2
    Catalog Number
    901008
    Company Name
    PaloDEx Group Oy
    Labeler DUNS
    459955188
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-03-16
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    221d1c7c-a3fb-47b4-bd47-6b1298b02957

    Device Characteristics

    Single Use
    No
    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
    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
    44245 Stationary panoramic/tomographic dental x-ray system, digital

    Identifiers

    Type ID
    Primary 06430035872701

    Customer Contacts

    Phone
    8005586120
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K092591 000