MapCHECK 3 11780000Z

GUDID 05060608880003

Radiation therapy QA device.

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: 05060608880003
• NIH Device Record Key: 3e3b13b3-4335-4bf6-98d5-f08afd783849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MapCHECK 3
• Version Model Number: 1178400Z
• Catalog Number: 11780000Z
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880003 [Primary]
HIBCC	B01611780000Z0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131466

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: 2019-04-23
• Device Publish Date: 2019-04-15

On-Brand Devices [MapCHECK 3]

• B01611780000Z0: Radiation therapy QA device.
• 05060608880003: Radiation therapy QA device.