BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    LAPAROSCOPE FIXATION HOLDER

    DI: B09928901500 · Model: 28901-50 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LAPAROSCOPE FIXATION HOLDER
    Primary DI
    B09928901500
    Version / Model
    28901-50
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    5
    Public Version Date
    2018-06-22
    Public Version Status
    Update
    Public Device Record Key
    b4d77811-16cc-4764-a4a7-8ad145e2019f
    Distribution End Date
    2018-06-22

    Device Description

    FIXATION LAPAROSCOPE HOLDER WITH FLEXIBLE SNAKE ARM

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    NWV Laparoscopic Accessories, Gynecologic

    GMDN Terms

    Code Name
    36302 Laparoscopic mechanical-distention system

    Identifiers

    Type ID
    Primary B09928901500

    Customer Contacts

    Phone
    8008217496
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Height 28 Inch