BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    O-ARM®

    DI: 00643169869844 · Model: BI71000547 · 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
    00643169869844
    Version / Model
    BI71000547
    Company Name
    MEDTRONIC NAVIGATION, INC.
    Labeler DUNS
    803580559
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-16
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    3c158c08-ac2e-4724-9b80-6250732b4cb9

    Device Description

    KIT SVC O2 BI71000547 COMP MVS SER 4.0.2

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    OWB Interventional fluoroscopic x-ray system

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00643169869844

    Customer Contacts

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