BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    3D TPR

    DI: 05060608880928 · Model: 1230000-4Z · SUN NUCLEAR CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    3D TPR
    Primary DI
    05060608880928
    Version / Model
    1230000-4Z
    Catalog Number
    1230000-4Z
    Company Name
    SUN NUCLEAR CORP.
    Labeler DUNS
    122240021
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-02
    Public Version
    2
    Public Version Date
    2020-06-30
    Public Version Status
    Update
    Public Device Record Key
    d2eadf9b-563a-4274-9e37-21b104d2da71

    Device Description

    Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio.

    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
    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
    IYE Accelerator, Linear, Medical

    GMDN Terms

    Code Name
    38399 Accelerator system quality assurance device

    Identifiers

    Type ID
    Primary 05060608880928
    Previous B01612300004Z0

    Premarket Submissions

    Submission Number Supplement Number
    K101992 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Never expose the 3D TPR electronic circuits to the direct radiation beam.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Store 3D TPR in an indoor, climate-controlled environment where it 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
    Do not store the instrument in the treatment room.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Never leave the instrument on the couch during delivery system warm up.
    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 Atmospheric Pressure
    Temperature Range
    57.2 – 106 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    For transport and storage within the facility, 3D TPR can remain attached to the Water Tank, but it is recommended to store 3D TPR in its case when not in use.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Do not keep 3D TPR in water longer than 24 hours.
    Type
    Special Storage Condition, Specify
    Special Conditions
    If connector is accidentally immersed in water, allow to dry completely before connecting to 3D SCANNER.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Ensure that all 3D TPR parts, including cable and connector, are clean and dry before placing in storage case. Dry with soft cloth. Never use abrasive cleaners.