INTRABEAM® Flat Applicator Set 5.0 cm

GUDID 04049539101532

Carl Zeiss Meditec AG

Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator

• Primary Device ID: 04049539101532
• NIH Device Record Key: 1f48aed0-22ee-4a50-9cb2-a0b5c18f95bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRABEAM® Flat Applicator Set 5.0 cm
• Version Model Number: 304534-3001-569
• 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: false
• 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 Dimensions

• Outer Diameter: 5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049539101532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130549

FDA Product Code

• JAD: System, Therapeutic, X-Ray

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04049539101532]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-14

Devices Manufactured by Carl Zeiss Meditec AG

• 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