BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SNC125c (TNC)

    DI: 05060608880225 · Model: 1041700Z · SUN NUCLEAR CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SNC125c (TNC)
    Primary DI
    05060608880225
    Version / Model
    1041700Z
    Catalog Number
    1041000-1Z
    Company Name
    SUN NUCLEAR CORP.
    Labeler DUNS
    122240021
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-04
    Public Version
    1
    Public Version Date
    2019-04-12
    Public Version Status
    New
    Public Device Record Key
    395126c8-6b56-4cdf-9115-285c73991a84

    Device Description

    Radiation therapy QA 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
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LHN System, Radiation Therapy, Charged-Particle, Medical

    GMDN Terms

    Code Name
    38336 Solid-state-semiconductor radiation measuring probe

    Identifiers

    Type ID
    Primary 05060608880225
    Previous B01610410001Z0

    Premarket Submissions

    Submission Number Supplement Number
    K112981 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    The storage case supplied with the SNC125c is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Store the SNC125c and accessories in the appropriate foam cutouts. To avoid damage to the SNC125c chamber, do not store buildup caps or other accessories loose in the storage case.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Store the SNC125c/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
    Type
    Special Storage Condition, Specify
    Special Conditions
    If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    57.2 – 106 KiloPascal
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    18.7 – 106 KiloPascal
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    -30 – 50 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius