BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    O-ARM®

    DI: 20643169803002 · Model: 9732721 · MEDTRONIC NAVIGATION, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    O-ARM®
    Primary DI
    20643169803002
    Version / Model
    9732721
    Company Name
    MEDTRONIC NAVIGATION, INC.
    Labeler DUNS
    803580559
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2017-08-12
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    50f12f63-e910-455a-9ee0-43a191dbfb03

    Device Description

    MOUSE 9732721 STERILE O-ARM 10

    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
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OXO Image-intensified fluoroscopic x-ray system, mobile

    GMDN Terms

    Code Name
    37649 Portable general-purpose fluoroscopic x-ray system, digital

    Identifiers

    Type ID
    Primary 20643169803002
    Unit of Use 00643169803008

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K060344 000