MapPHAN (5cm) 10830000

GUDID B016108300000

Accessory to Model 1177 MapCHECK 2.

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: B016108300000
• NIH Device Record Key: 3950a0f8-f175-4f1e-a0d1-fb93f7f06b36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MapPHAN (5cm)
• Version Model Number: 10830000
• Catalog Number: 10830000
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid wearing jewelry on hands when handling the phantoms.
• Special Storage Condition, Specify: Between 0 and 0 *The phantoms are fragile. Handle gently and avoid bumping against other objects.
• Special Storage Condition, Specify: Between 0 and 0 *MapPHAN is constructed from water equivalent material, which must be handled carefully to prevent damage such as scratching, warping, breaking, or discoloration.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store anything on top of the phantom.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *Store water equivalent phantoms in an indoor, protected environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store water equivalent phantoms on a flat, level surface.
• Special Storage Condition, Specify: Between 0 and 0 *Do not place anything directly on the surface of a phantom.
• Special Storage Condition, Specify: Between 0 and 0 *To prevent scratches on water equivalent phantoms, do not use the phantoms as a writing surface.
• Special Storage Condition, Specify: Between 0 and 0 *Do not write on a phantom with a permanent marker since the ink cannot be removed.
• Special Storage Condition, Specify: Between 0 and 0 *Do not immerse the phantom in any fluid. Do not use abrasive cleaners.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *When cleaning, wipe with the grain of the phantom, not in a circular motion.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid wearing jewelry on hands when handling the phantoms.
• Special Storage Condition, Specify: Between 0 and 0 *The phantoms are fragile. Handle gently and avoid bumping against other objects.
• Special Storage Condition, Specify: Between 0 and 0 *MapPHAN is constructed from water equivalent material, which must be handled carefully to prevent damage such as scratching, warping, breaking, or discoloration.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store anything on top of the phantom.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *Store water equivalent phantoms in an indoor, protected environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store water equivalent phantoms on a flat, level surface.
• Special Storage Condition, Specify: Between 0 and 0 *Do not place anything directly on the surface of a phantom.
• Special Storage Condition, Specify: Between 0 and 0 *To prevent scratches on water equivalent phantoms, do not use the phantoms as a writing surface.
• Special Storage Condition, Specify: Between 0 and 0 *Do not write on a phantom with a permanent marker since the ink cannot be removed.
• Special Storage Condition, Specify: Between 0 and 0 *Do not immerse the phantom in any fluid. Do not use abrasive cleaners.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *When cleaning, wipe with the grain of the phantom, not in a circular motion.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B016108300000 [Primary]

FDA Product Code

• IXG: Phantom, Anthropomorphic, Radiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-14

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