BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ICEfx Cryoablation System

    DI: 00859019006417 · Model: FPRCH8000-02 · BOSTON SCIENTIFIC CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ICEfx Cryoablation System
    Primary DI
    00859019006417
    Version / Model
    FPRCH8000-02
    Catalog Number
    FPRCH8000-02
    Company Name
    BOSTON SCIENTIFIC CORPORATION
    Labeler DUNS
    831630103
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-24
    Public Version
    6
    Public Version Date
    2022-04-08
    Public Version Status
    Update
    Public Device Record Key
    0f931419-ede7-4ff1-982b-95aea03cc389

    Device Description

    Cryoablation System

    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 00859019006417

    Customer Contacts

    Phone
    651-287-5000
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    -15 – 50 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity