BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    NA

    DI: 00681490069298 · Model: 3118515 · MEDTRONIC XOMED, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    00681490069298
    Version / Model
    3118515
    Company Name
    MEDTRONIC XOMED, INC.
    Labeler DUNS
    835465063
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-02
    Public Version
    5
    Public Version Date
    2019-10-23
    Public Version Status
    Update
    Public Device Record Key
    d6ea6070-970e-4f25-b1bb-a61c389269b5
    Distribution End Date
    2018-10-24

    Device Description

    STYLETS 3118515 10PK IRRIGATION

    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
    No

    Product Codes

    Code Name
    ERL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

    GMDN Terms

    Code Name
    64128 Surgical instrument/endoscope cleaning adaptor

    Identifiers

    Type ID
    Package 20681490069292
    Primary 00681490069298

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K791407 000