BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MapPHAN (5cm)

    DI: B016108300000 · Model: 10830000 · SUN NUCLEAR CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MapPHAN (5cm)
    Primary DI
    B016108300000
    Version / Model
    10830000
    Catalog Number
    10830000
    Company Name
    SUN NUCLEAR CORP.
    Labeler DUNS
    122240021
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-14
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    3950a0f8-f175-4f1e-a0d1-fb93f7f06b36

    Device Description

    Accessory to Model 1177 MapCHECK 2.

    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
    IXG Phantom, Anthropomorphic, Radiographic

    GMDN Terms

    Code Name
    38399 Accelerator system quality assurance device

    Identifiers

    Type ID
    Primary B016108300000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Avoid wearing jewelry on hands when handling the phantoms.
    Type
    Special Storage Condition, Specify
    Special Conditions
    The phantoms are fragile. Handle gently and avoid bumping against other objects.
    Type
    Special Storage Condition, Specify
    Special Conditions
    MapPHAN is constructed from water equivalent material, which must be handled carefully to prevent damage such as scratching, warping, breaking, or discoloration.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Before handling the phantoms, wash hands thoroughly to prevent fingerprints, which cannot be removed. Fingerprints can be caused by regular skin oils, hand lotion, or petroleum jelly.
    Type
    Special Storage Condition, Specify
    Special Conditions
    To prevent warping or breaking of thinner phantoms, do not place a thicker phantom on top of a thinner phantom. For example, a 10.0 cm phantom must not be stored on top of a 5.0 cm phantom.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Do not store anything on top of the phantom.
    Type
    Special Storage Condition, Specify
    Special Conditions
    The phantoms will change color when exposed to sunlight. If phantoms are not stored in a closed cabinet or box, cover phantoms with black plastic bags.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Store water equivalent phantoms in an indoor, protected environment.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Store water equivalent phantoms on a flat, level surface.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Do not place anything directly on the surface of a phantom.
    Type
    Special Storage Condition, Specify
    Special Conditions
    To prevent scratches on water equivalent phantoms, do not use the phantoms as a writing surface.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Do not write on a phantom with a permanent marker since the ink cannot be removed.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Do not immerse the phantom in any fluid. Do not use abrasive cleaners.
    Type
    Special Storage Condition, Specify
    Special Conditions
    To remove dust or other light debris from the surface, use a clean paper towel and a small amount of 100% alcohol. Do not use the first or last sheet of a paper towel roll, as it may contain adhesive.
    Type
    Special Storage Condition, Specify
    Special Conditions
    When cleaning, wipe with the grain of the phantom, not in a circular motion.