BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SET OPTIMA MX2 EDUCATIONAL 6

    DI: J007170081701 · Model: 1700817-0 · Bien-Air Dental SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SET OPTIMA MX2 EDUCATIONAL 6
    Primary DI
    J007170081701
    Version / Model
    1700817-0
    Catalog Number
    1700817-0
    Company Name
    Bien-Air Dental SA
    Labeler DUNS
    480082080
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-13
    Public Version
    1
    Public Version Date
    2023-12-21
    Public Version Status
    New
    Public Device Record Key
    db011faf-b51b-4544-a0ea-a15357e6a7c1

    Device Description

    Optima consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connected to a dental pneumatic unit.

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EIA Unit, Operative Dental

    GMDN Terms

    Code Name
    41264 Surgical power tool system control unit, line-powered

    Identifiers

    Type ID
    Primary J007170081701

    Customer Contacts

    Phone
    +1 949-477-6050
    Email
    [email protected]