BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MICTEC VESSEL SPATULA

    DI: B09920942160 · Model: 20942-16 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MICTEC VESSEL SPATULA
    Primary DI
    B09920942160
    Version / Model
    20942-16
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-30
    Public Version
    5
    Public Version Date
    2018-09-24
    Public Version Status
    Update
    Public Device Record Key
    1e6bc5e4-343f-40af-90de-7f86a5043f12
    Distribution End Date
    2018-09-23

    Device Description

    MICTEC VESSEL SPATULA

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

    Product Codes

    Code Name
    GCJ Laparoscope, General & Plastic Surgery

    GMDN Terms

    Code Name
    38127 Vascular spatula

    Identifiers

    Type ID
    Primary B09920942160

    Customer Contacts

    Phone
    800-821-7496
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K002877 000

    Device Sizes

    Type Value Unit Text
    Length 300 Millimeter