BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IMACTIS®

    DI: B681J000970 · Model: J00097 · IMACTIS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    IMACTIS®
    Primary DI
    B681J000970
    Version / Model
    J00097
    Catalog Number
    MA-J00097
    Company Name
    IMACTIS
    Labeler DUNS
    260527568
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-12-08
    Public Version
    2
    Public Version Date
    2025-09-23
    Public Version Status
    Update
    Public Device Record Key
    dce00d62-728a-4172-a2a9-2dcea6df2dde

    Device Description

    Cart for the IMACTIS® CT-NAVIGATION system

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment)

    GMDN Terms

    Code Name
    36801 Utility trolley

    Identifiers

    Type ID
    Primary B681J000970
    Package B681J000971