BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    3D MiniLift

    DI: 05060608880324 · Model: 1231600Z · SUN NUCLEAR CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    3D MiniLift
    Primary DI
    05060608880324
    Version / Model
    1231600Z
    Catalog Number
    1230000-3Z
    Company Name
    SUN NUCLEAR CORP.
    Labeler DUNS
    122240021
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-28
    Public Version
    1
    Public Version Date
    2019-06-05
    Public Version Status
    New
    Public Device Record Key
    4e818222-51bd-460c-8c57-87526de5c07d

    Device Description

    Accessory to the 3D SCANNER 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
    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 05060608880324

    Premarket Submissions

    Submission Number Supplement Number
    K101992 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Fingers can be pinched when changing the 3D MiniLift leg positions. Keep hands clear of the Leg joints and Frame when changing the Leg positions.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Remove all water from the 3D SCANNER before changing the 3D MiniLift Leg positions.
    Type
    Special Storage Condition, Specify
    Special Conditions
    The 3D SCANNER, 3D MiniLift or 3D Lift, and Automatic Leveling Platform must be stored in an indoor air-conditioned location.
    Type
    Special Storage Condition, Specify
    Special Conditions
    If the 3D SCANNER, 3D MiniLift, or 3D Lift were shipped in a wood crate, do not re-use the crate for storage or shipping. Accessory shipping cases are available.
    Type
    Special Storage Condition, Specify
    Special Conditions
    For transport and storage within the facility, the 3D SCANNER water tank can remain attached to the 3D MiniLift or 3D Lift as well as the Automatic Leveling Platform.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Store the 3D SCANNER system 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
    A two-person lift is required for the 3D MiniLift Frame and Lift Subassembly. Use proper lifting techniques to avoid injury.
    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
    Do not store any radiation sensitive electronic equipment in the 3D Lift storage compartments.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Never store the 3D SCANNER system, associated parts, or accessories inside the treatment room.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Never store the 3D SCANNER system in an area that is under construction. Excessive dust may reduce the precision of the 3D SCANNER motors and mechanical parts.
    Type
    Special Storage Condition, Specify
    Special Conditions
    When shipping/transporting the 3D SCANNER system between facilities, it is recommended to use the accessory shipping cases for the 3D SCANNER Water Tank, Automatic Leveling Platform, and 3D MiniLift.
    Type
    Special Storage Condition, Specify
    Special Conditions
    When measurement is complete, the 3D SCANNER Water Tank can remain attached to the Automatic Leveling Platform and 3D MiniLift or 3D Lift (recommended).