Calypso Beacon Care Package-Lung ASM0341

GUDID 00850011006122

VARIAN MEDICAL SYSTEMS, INC.

Implanted-marker patient positioning system

• Primary Device ID: 00850011006122
• NIH Device Record Key: cd2dcf3d-8d2b-468f-97b7-029f39c05c42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calypso Beacon Care Package-Lung
• Version Model Number: 2
• Catalog Number: ASM0341
• Company DUNS: 070809675
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850011006122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170570

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-20
• Device Publish Date: 2019-09-12

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