BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NuFACE

    DI: 00850019720563 · Model: 42011 · Nuface
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NuFACE
    Primary DI
    00850019720563
    Version / Model
    42011
    Company Name
    Nuface
    Labeler DUNS
    023980008
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-08
    Public Version
    1
    Public Version Date
    2023-06-16
    Public Version Status
    New
    Public Device Record Key
    7ef4e4d5-b262-4750-9761-16abd0057511

    Device Description

    Trinity+ PRO ELE+ Kit - White

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 00850019720563

    Premarket Submissions

    Submission Number Supplement Number
    K201782 000
    K201906 000