BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Winback Back 3SE

    DI: 08800092010855 · Model: 1085 · Daeyang Medical Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Winback Back 3SE
    Primary DI
    08800092010855
    Version / Model
    1085
    Company Name
    Daeyang Medical Co., Ltd.
    Labeler DUNS
    688463749
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-18
    Public Version
    2
    Public Version Date
    2021-09-20
    Public Version Status
    Update
    Public Device Record Key
    1b877339-8348-4ce4-951a-29a243948ba8

    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
    PBX Massager, Vacuum, Radio Frequency Induced Heat

    GMDN Terms

    Code Name
    61186 Multi-modality physical therapy system

    Identifiers

    Type ID
    Primary 08800092010855

    Customer Contacts

    Phone
    +330483661666
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K162828 000