BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    STRETCH PIN

    DI: 00192896000223 · Model: 15-30116-07 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    STRETCH PIN
    Primary DI
    00192896000223
    Version / Model
    15-30116-07
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-20
    Public Version
    1
    Public Version Date
    2018-09-20
    Public Version Status
    New
    Public Device Record Key
    9c11bfa5-8d2f-447e-9f05-d4fb787adb13

    Device Description

    STRECH PIN FOR FLEXIBLE TROCAR SLEEVE

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

    Product Codes

    Code Name
    GCJ Laparoscope, General & Plastic Surgery

    GMDN Terms

    Code Name
    62452 Laparoscopic multi-instrument access port, reusable

    Identifiers

    Type ID
    Previous B0991530116070
    Primary 00192896000223

    Customer Contacts

    Phone
    8008217496
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K002877 000

    Device Sizes

    Type Value Unit Text
    Width 7 Millimeter