SNC350p (BNC) 1045000-0Z

GUDID 05060608880126

Radiation therapy QA device.

SUN NUCLEAR CORP.

Solid-state-semiconductor radiation measuring probe

• Primary Device ID: 05060608880126
• NIH Device Record Key: 88e653c7-7820-4daa-a03c-36689c59aa6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SNC350p (BNC)
• Version Model Number: 1045300Z
• Catalog Number: 1045000-0Z
• 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 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880126 [Primary]
HIBCC	B01610450000Z0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112981

FDA Product Code

• LHN: System, Radiation Therapy, Charged-Particle, 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: 2019-10-09
• Device Publish Date: 2019-10-01

On-Brand Devices [SNC350p (BNC)]

• B01610450000Z0: Radiation therapy QA device.
• 05060608880126: Radiation therapy QA device.