ArcCHECK-MR 12200000MR

GUDID 05060608880355

Radiation therapy QA device.

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: 05060608880355
• NIH Device Record Key: 6f7984a6-1c8a-42a1-aac6-e038528039f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArcCHECK-MR
• Version Model Number: 12200000MR
• Catalog Number: 12200000MR
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880355 [Primary]
HIBCC	B01612200000MR0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160057

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2020-06-30
• Device Publish Date: 2019-05-28

On-Brand Devices [ArcCHECK-MR]

• B01612200000MR0: Radiation therapy QA device.
• 05060608880355: Radiation therapy QA device.