WaterProof PROFILER 12300009Z

GUDID B01612300009Z0

Radiation Therapy QA Device. For use with the 1230 3D SCANNER.

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: B01612300009Z0
• NIH Device Record Key: 6dfc729e-af0e-4d5a-b858-63431c56be1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaterProof PROFILER
• Version Model Number: 1203300Z
• Catalog Number: 12300009Z
• 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument in the treatment room.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880317 [Primary]
HIBCC	B01612300009Z0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142431

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-03
• Device Publish Date: 2019-09-25

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