BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NIM

    DI: 20763000112459 · Model: 8225825X · MEDTRONIC XOMED, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    NIM
    Primary DI
    20763000112459
    Version / Model
    8225825X
    Company Name
    MEDTRONIC XOMED, INC.
    Labeler DUNS
    835465063
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2022-06-17
    Public Version
    2
    Public Version Date
    2023-01-24
    Public Version Status
    Update
    Public Device Record Key
    2d4a8eb8-edef-49c1-b2f8-5d2976dbe469

    Device Description

    PROBE 8225825X 3PK INCREMT STD PRASS TIP

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ETN STIMULATOR, NERVE

    GMDN Terms

    Code Name
    61089 Nerve-locating system probe, single-use

    Identifiers

    Type ID
    Unit of Use 00763000112455
    Primary 20763000112459

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K213246 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -29 – 60 Degrees Celsius