INTRABEAM

GUDID 04049539064080

The INTRABEAM 700 is a medical device used in the context of Radiation Therapy. It is used unsterile given that it shall be placed in the environment of the operating theatre, but outside of the sterile medical environment. It is intended to deliver, monitor, and report a radiation therapy treatment.

Carl Zeiss Meditec AG

Intraoperative/postoperative therapeutic x-ray system

• Primary Device ID: 04049539064080
• NIH Device Record Key: 66a2af8b-6b5b-497b-a97f-d6f29dde1af8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRABEAM
• Version Model Number: 700
• Company DUNS: 342228620
• Company Name: Carl Zeiss Meditec AG
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049539064080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241174

FDA Product Code

• JAD: System, Therapeutic, X-Ray

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: 2025-04-09
• Device Publish Date: 2025-04-01

Devices Manufactured by Carl Zeiss Meditec AG

• 04049539064080 - INTRABEAM: 2025-04-09The INTRABEAM 700 is a medical device used in the context of Radiation Therapy. It is used unsterile given that it shall be placed in the environment of the operating theatre, but outside of the sterile medical environment. It is intended to deliver, monitor, and report a radiation therapy treatment.
• 04049539064080 - INTRABEAM: 2025-04-09 The INTRABEAM 700 is a medical device used in the context of Radiation Therapy. It is used unsterile given that it shall be pla
• 04049539066503 - INTRABEAM SMART Stand: 2025-04-09 The INTRABEAM SMART Stand is connected to the INTRABEAM 700 (Workplace). The INTABEAM SMART Stand shall be used to mount the X-
• 04049539066435 - TIVATO® 700: 2025-01-30
• 04049539106018 - SMARTDRAPE: 2025-01-30
• 04049539106070 - INTRABEAM SMARTDRAPE: 2025-01-30
• 04049539106094 - SMARTDRAPE: 2025-01-30
• 04049539106889 - EyeMag Smart TTL: 2025-01-30
• 04049539106896 - EyeMag Classic: 2025-01-30