BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Axial Handle

    DI: 00192896115774 · Model: 2901-082 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Axial Handle
    Primary DI
    00192896115774
    Version / Model
    2901-082
    Catalog Number
    2901-082
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-11-03
    Public Version
    1
    Public Version Date
    2023-11-13
    Public Version Status
    New
    Public Device Record Key
    1da02ddf-c168-4180-83ff-193783f2b9e0

    Device Description

    Axial Handle Angled With Spring And Ratchet For 3 Millimeter, 5 Millimeter, and 10 Millimeter Diameter Tube Shafts

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

    Product Codes

    Code Name
    GEI Electrosurgical, cutting & coagulation & accessories

    GMDN Terms

    Code Name
    63868 Laparoscopic surgery handle

    Identifiers

    Type ID
    Primary 00192896115774

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K102921 000