Halcyon

GUDID 00857235006020

Varian Medical Systems China Co., Ltd.

Linear accelerator system

• Primary Device ID: 00857235006020
• NIH Device Record Key: 49846da4-18e6-48a4-baf4-549f53af4508
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halcyon
• Version Model Number: 2.0
• Company DUNS: 545295284
• Company Name: Varian Medical Systems China Co., Ltd.
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857235006020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181032

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: 2019-06-10
• Device Publish Date: 2019-05-31

On-Brand Devices [Halcyon]

• 00857235006006: 1.0
• 00857235006020: 2.0