BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    FREEZE POINT DEVICE

    DI: 00192896009332 · Model: CRY16 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FREEZE POINT DEVICE
    Primary DI
    00192896009332
    Version / Model
    CRY16
    Catalog Number
    CRY16
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-15
    Public Version
    2
    Public Version Date
    2020-10-19
    Public Version Status
    Update
    Public Device Record Key
    99e0acf3-cfbf-4d9c-8264-e74d4257a3ae
    Distribution End Date
    2020-10-16

    Device Description

    FREEZE POINT DEVICE

    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
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    GEH Unit, Cryosurgical, Accessories

    GMDN Terms

    Code Name
    61876 Open-surgery electrosurgical electrode, monopolar, reusable

    Identifiers

    Type ID
    Primary 00192896009332

    Customer Contacts

    Phone
    800-821-7496
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K102006 000