BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GROOVED DIRECTOR

    DI: 00192896076679 · Model: 197-693 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GROOVED DIRECTOR
    Primary DI
    00192896076679
    Version / Model
    197-693
    Catalog Number
    197-693
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-20
    Public Version
    3
    Public Version Date
    2023-07-20
    Public Version Status
    Update
    Public Device Record Key
    f607fa0d-aff0-4b76-9f6c-0a45bbbb97e2

    Device Description

    GROOVED DIRECTOR TONGUE TIE STAINLESS STEEL

    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
    Yes
    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
    ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    FGM Probe And Director, Gastro-Urology

    GMDN Terms

    Code Name
    46486 Gastro-urological director

    Identifiers

    Type ID
    Primary 00192896076679

    Customer Contacts

    Phone
    +1(800) 821-7496
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 6 Inch