BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Freezpen®

    DI: B386CLFP010 · Model: Freezpen 8G · H & O Equipments SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Freezpen®
    Primary DI
    B386CLFP010
    Version / Model
    Freezpen 8G
    Catalog Number
    CL-FP-01
    Company Name
    H & O Equipments SA
    Labeler DUNS
    370212933
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-06
    Public Version
    4
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    17eb29bd-784d-447e-83ed-0afb6793f8d9

    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
    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
    GEH Unit, Cryosurgical, Accessories

    GMDN Terms

    Code Name
    60509 Nitrous oxide gas cartridge

    Identifiers

    Type ID
    Primary B386CLFP010

    Customer Contacts

    Phone
    888-2482838
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K024009 000