BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Visual-ICE™ MRI

    DI: 00191506036522 · Model: H7493961070000 · BOSTON SCIENTIFIC CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Visual-ICE™ MRI
    Primary DI
    00191506036522
    Version / Model
    H7493961070000
    Catalog Number
    H7493961070000
    Company Name
    BOSTON SCIENTIFIC CORPORATION
    Labeler DUNS
    021717889
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-12
    Public Version
    1
    Public Version Date
    2023-04-20
    Public Version Status
    New
    Public Device Record Key
    1c3292f8-1a87-4d4c-be75-bb09d621e9fe

    Device Description

    Visual-ICE™ MRI Cryoablation Console

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEH UNIT, CRYOSURGICAL, ACCESSORIES

    GMDN Terms

    Code Name
    45738 General cryosurgical system, cryogen gas, electronic

    Identifiers

    Type ID
    Primary 00191506036522
    Previous 00859019006318