BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EOS

    DI: 04712568360255 · Model: EosSmear · NORTH EOS INDUSTRIES INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    EOS
    Primary DI
    04712568360255
    Version / Model
    EosSmear
    Company Name
    NORTH EOS INDUSTRIES INC.
    Labeler DUNS
    656812989
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-10
    Public Version
    1
    Public Version Date
    2018-09-10
    Public Version Status
    New
    Public Device Record Key
    36ae56f7-8992-463b-b4ae-ed357ead4b8d

    Device Description

    EOS DISPOSABLE CERVICAL SAMPLER

    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
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HHT Spatula, Cervical, Cytological

    GMDN Terms

    Code Name
    32679 Cervical cytology scraper, single-use

    Identifiers

    Type ID
    Primary 04712568360255

    Premarket Submissions

    Submission Number Supplement Number
    K963685 000