BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    O-arm

    DI: 00763000616564 · Model: BI70002000 · MEDTRONIC NAVIGATION, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    O-arm
    Primary DI
    00763000616564
    Version / Model
    BI70002000
    Company Name
    MEDTRONIC NAVIGATION, INC.
    Labeler DUNS
    803580559
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-29
    Public Version
    1
    Public Version Date
    2022-05-09
    Public Version Status
    New
    Public Device Record Key
    1e374672-33b8-4a86-ba0a-bee6f486cdb3

    Device Description

    O-ARM SYS BI70002000 O2 UE 120V B EN UEN

    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
    OWB Interventional fluoroscopic x-ray system
    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 00763000616564

    Customer Contacts

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