BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    McCarus-Volker FORNISEE® SYSTEM

    DI: 00850200006377 · Model: 110105 · LSI Solutions, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    McCarus-Volker FORNISEE® SYSTEM
    Primary DI
    00850200006377
    Version / Model
    110105
    Catalog Number
    110105
    Company Name
    LSI Solutions, Inc.
    Labeler DUNS
    603420183
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    5
    Public Version Date
    2022-11-10
    Public Version Status
    Update
    Public Device Record Key
    8f3c0804-bda9-4006-91c0-20bc70a56f1f

    Device Description

    10cm FS® SOUND - SINGLE

    Device Characteristics

    Single Use
    No
    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
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Hydrogen Peroxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    LKF Cannula, Manipulator/Injector, Uterine

    GMDN Terms

    Code Name
    13644 Uterine sound, reusable

    Identifiers

    Type ID
    Primary 00850200006377

    Customer Contacts

    Phone
    +1(866)575-3493
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K111014 000

    Device Sizes

    Type Value Unit Text
    Length 10 Centimeter