Mobius3D

GUDID 00850800006043

VARIAN MEDICAL SYSTEMS, INC.

Radiation therapy software

• Primary Device ID: 00850800006043
• NIH Device Record Key: c61aa36d-200c-440f-81de-bf73f768cfb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mobius3D
• Version Model Number: 4.0
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• 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: true
• Serial Number: false
• 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	00850800006043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203669

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: 2021-02-01
• Device Publish Date: 2021-01-23

On-Brand Devices [Mobius3D]

• 08613340003001: Secondary Check QA Software
• 00861334000315: Secondary Check QA Software
• 00850800006043: 4.0