BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sinrel

    DI: 06975785860009 · Model: YF1503 · Shenzhen Yuehua Xinsen Technology Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sinrel
    Primary DI
    06975785860009
    Version / Model
    YF1503
    Company Name
    Shenzhen Yuehua Xinsen Technology Co., Ltd.
    Labeler DUNS
    417886675
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-26
    Public Version
    1
    Public Version Date
    2023-04-03
    Public Version Status
    New
    Public Device Record Key
    2cc4f6c5-4150-4ec2-9e88-8632314e874b

    Device Description

    TENS & PMS Unit

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

    GMDN Terms

    Code Name
    35372 Analgesic transcutaneous electrical nerve stimulation system

    Identifiers

    Type ID
    Package 16975785860006
    Primary 06975785860009
    Package 26975785860003
    Package 36975785860000

    Premarket Submissions

    Submission Number Supplement Number
    K220005 000