BRAVOS Afterloader System VG15001002

GUDID 00816389029200

Varian Medical Systems Deutschland GmbH

Remote-afterloading brachytherapy system

• Primary Device ID: 00816389029200
• NIH Device Record Key: 2f3b4bbc-4fba-491c-b7da-f9f346b25d76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRAVOS Afterloader System
• Version Model Number: 1.2
• Catalog Number: VG15001002
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• 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	00816389029200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221797

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

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: 2022-10-03
• Device Publish Date: 2022-09-23

On-Brand Devices [BRAVOS Afterloader System]

• 00816389027947: Bravos Afterloader System
• 00816389029200: 1.2