BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Yomi S Draping Kit

    DI: 00810004900820 · Model: DRW-3638-00 · NEOCIS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Yomi S Draping Kit
    Primary DI
    00810004900820
    Version / Model
    DRW-3638-00
    Company Name
    NEOCIS INC
    Labeler DUNS
    802312434
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-01
    Public Version
    1
    Public Version Date
    2025-12-09
    Public Version Status
    New
    Public Device Record Key
    a3c57820-9bd9-4e8e-9f0e-3e157a127fe4

    Device Description

    Yomi S Draping Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    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
    PLV Dental Stereotaxic Instrument

    GMDN Terms

    Code Name
    45197 Dental stereotactic surgery system

    Identifiers

    Type ID
    Primary 00810004900820

    Premarket Submissions

    Submission Number Supplement Number
    K252376 000