BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CoolSculpting Elite Control Unit

    DI: 00816417021619 · Model: CS-S3-002-D-00 · Zeltiq Aesthetics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CoolSculpting Elite Control Unit
    Primary DI
    00816417021619
    Version / Model
    CS-S3-002-D-00
    Company Name
    Zeltiq Aesthetics, Inc.
    Labeler DUNS
    809152916
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-31
    Public Version
    1
    Public Version Date
    2020-09-08
    Public Version Status
    New
    Public Device Record Key
    b5e16267-0ad6-4402-a625-619b6cc5e7e6

    Device Description

    CoolSculpting Elite Control 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
    No

    Product Codes

    Code Name
    OOK Dermal Cooling Pack/Vacuum/Massager

    GMDN Terms

    Code Name
    56308 Cryolipolysis body contouring system control unit

    Identifiers

    Type ID
    Primary 00816417021619