BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Heartline MIS Bulldog Aortic Clamp

    DI: 00192896119420 · Model: 2800-7908 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Heartline MIS Bulldog Aortic Clamp
    Primary DI
    00192896119420
    Version / Model
    2800-7908
    Catalog Number
    2800-7908
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-09-04
    Public Version
    1
    Public Version Date
    2024-09-12
    Public Version Status
    New
    Public Device Record Key
    8a7e87e4-cbca-4a03-b56b-f0e447acda95

    Device Description

    Heartline MIS Bulldog Aortic Clamp Curved

    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
    Yes
    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

    Product Codes

    Code Name
    DXC CLAMP, VASCULAR

    GMDN Terms

    Code Name
    62470 Surgical bulldog clamp, reusable

    Identifiers

    Type ID
    Primary 00192896119420

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K092544 000

    Device Sizes

    Type Value Unit Text
    Length 110 Millimeter