Calypso Beacon Care Package-Lung ASM0341

GUDID 00850011006122

VARIAN MEDICAL SYSTEMS, INC.

Implanted-marker patient positioning system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization 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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