BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    O-ARM®

    DI: 00643169589292 · Model: BI70000028120R · MEDTRONIC NAVIGATION, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    O-ARM®
    Primary DI
    00643169589292
    Version / Model
    BI70000028120R
    Company Name
    MEDTRONIC NAVIGATION, INC.
    Labeler DUNS
    803580559
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-17
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    743e6a27-276b-4350-8cb8-1c54b88c2241

    Device Description

    OARM BI70000028120R SYS 120V ENGLISH RWK

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    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 00643169589292

    Customer Contacts

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