BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vario-Pedal

    DI: ENOU1511NOU0 · Model: 1511NOU · Nouvag AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Vario-Pedal
    Primary DI
    ENOU1511NOU0
    Version / Model
    1511NOU
    Company Name
    Nouvag AG
    Labeler DUNS
    480610476
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-13
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    451fbca4-49f3-4ee3-b798-7a435aab0bfe

    Device Description

    Vario-Pedal for Dispenser DP 30 LipoPlus

    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
    FRN Pump, Infusion

    GMDN Terms

    Code Name
    36336 Foot-switch, electrical

    Identifiers

    Type ID
    Primary ENOU1511NOU0

    Customer Contacts

    Phone
    +41718466600
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K071588 000