BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CannulaCRF

    DI: 00811746030028 · Model: CRF-C1030 · CAMBRIDGE INTERVENTIONAL LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CannulaCRF
    Primary DI
    00811746030028
    Version / Model
    CRF-C1030
    Catalog Number
    CRF-C1030
    Company Name
    CAMBRIDGE INTERVENTIONAL LLC
    Labeler DUNS
    080897872
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-30
    Public Version
    2
    Public Version Date
    2023-09-27
    Public Version Status
    Update
    Public Device Record Key
    a4acc035-c1e7-4053-b3cf-ca379179be56

    Device Description

    CRF Radiofrequency Cannula

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    58739 Percutaneous radio-frequency ablation probe cannula, single-use

    Identifiers

    Type ID
    Package 10811746030025
    Primary 00811746030028

    Customer Contacts

    Phone
    781-221-5300
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K192715 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 40 Degrees Celsius