BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Neutral Plate

    DI: 00810026180873 · Model: SIEC-NPD/1 · SONIQUENCE, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Neutral Plate
    Primary DI
    00810026180873
    Version / Model
    SIEC-NPD/1
    Catalog Number
    SIEC-NPD/1
    Company Name
    SONIQUENCE, LLC
    Labeler DUNS
    117308190
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-19
    Public Version
    1
    Public Version Date
    2020-05-27
    Public Version Status
    New
    Public Device Record Key
    113c6094-32e2-4463-9e47-1bfac23ec8ff

    Device Description

    Neutral plate (1 pc), disposable, large

    Device Characteristics

    Single Use
    Yes
    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    11500 Electrosurgical return electrode, single-use, sterile

    Identifiers

    Type ID
    Package 00810026180859
    Primary 00810026180873

    Premarket Submissions

    Submission Number Supplement Number
    K183611 000