BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CoolSculpting Elite Card, Direct, USA,CAN 20 Solo Trx

    DI: 00816417021381 · Model: CS-C2-D01-20-00 · Zeltiq Aesthetics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CoolSculpting Elite Card, Direct, USA,CAN 20 Solo Trx
    Primary DI
    00816417021381
    Version / Model
    CS-C2-D01-20-00
    Catalog Number
    CS-C2-D01-20-00
    Company Name
    Zeltiq Aesthetics, Inc.
    Labeler DUNS
    809152916
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-09
    Public Version
    1
    Public Version Date
    2020-12-17
    Public Version Status
    New
    Public Device Record Key
    a28587bd-bc65-421b-8628-e87b053886f5

    Device Description

    CoolSculpting Elite Card, Direct, USA,CAN 20 Solo Trx

    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
    56312 Cryolipolysis body contouring system program card

    Identifiers

    Type ID
    Primary 00816417021381

    Customer Contacts

    Phone
    888-935-8471
    Email
    [email protected]