BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Shenzhen Wells Optoelectronics Co.,Ltd.

    DI: 06977182810113 · Model: DZ01 · Shenzhen Wells Optoelectronics Co.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Shenzhen Wells Optoelectronics Co.,Ltd.
    Primary DI
    06977182810113
    Version / Model
    DZ01
    Company Name
    Shenzhen Wells Optoelectronics Co.,Ltd.
    Labeler DUNS
    549645451
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-16
    Public Version
    1
    Public Version Date
    2024-06-24
    Public Version Status
    New
    Public Device Record Key
    e5d21060-de8c-4f05-bc3e-2da6f8dfb190

    Device Description

    derma pen/DZ01

    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNM Device, Pressure Applying

    GMDN Terms

    Code Name
    45220 Multi-modality skin surface treatment system

    Identifiers

    Type ID
    Primary 06977182810113