SagiPlan® 2.x Software 1374-0600

GUDID 04049223132088

Eckert & Ziegler BEBIG GmbH

Radiation therapy software

• Primary Device ID: 04049223132088
• NIH Device Record Key: 30e87a1e-98bd-42a2-953d-66c24b56b985
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SagiPlan® 2.x Software
• Version Model Number: 1374-0600#03
• Catalog Number: 1374-0600
• Company DUNS: 331080432
• Company Name: Eckert & Ziegler BEBIG 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049223132088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141900

FDA Product Code

• MUJ: System, Planning, Radiation Therapy Treatment

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: 2020-07-09
• Device Publish Date: 2020-07-01

On-Brand Devices [SagiPlan® 2.x Software]

• 04049223118211: 1374-0600#01
• 04049223132088: 1374-0600#03