BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Cellfina Motor Module Device and Package

    DI: 00840763100544 · Model: CM1-EU Rev A · ULTHERA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cellfina Motor Module Device and Package
    Primary DI
    00840763100544
    Version / Model
    CM1-EU Rev A
    Company Name
    ULTHERA, INC.
    Labeler DUNS
    010981554
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-14
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    be69ab63-cb5f-481c-b00c-6a4b10ff6bc8
    Distribution End Date
    2016-09-07

    Device Description

    EU part should not have been registered with GUDID

    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
    OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

    GMDN Terms

    Code Name
    62247 Mechanical skin contouring system motor

    Identifiers

    Type ID
    Primary 00840763100544

    Premarket Submissions

    Submission Number Supplement Number
    K153677 000