Bravos Afterloader System VG15000500

GUDID 00816389027947

Bravos Afterloader System

Varian Medical Systems Deutschland GmbH

Remote-afterloading brachytherapy system

• Primary Device ID: 00816389027947
• NIH Device Record Key: 90ec880d-b68e-4a25-81e9-4b83ab86adfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bravos Afterloader System
• Version Model Number: VG15000500
• Catalog Number: VG15000500
• Company DUNS: 332474605
• Company Name: Varian Medical Systems Deutschland GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00816389027947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181903

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: 2018-12-17
• Device Publish Date: 2018-11-16

On-Brand Devices [Bravos Afterloader System]

• 00816389027947: Bravos Afterloader System
• 00816389029200: 1.2