INTRABEAM SMART Spherical Applicator

GUDID 04049539105523

Carl Zeiss Meditec AG

Intraoperative/postoperative therapeutic x-ray system spherical applicator, single-use

• Primary Device ID: 04049539105523
• NIH Device Record Key: 96980476-dbf1-4b35-b23c-f1825a470681
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRABEAM SMART Spherical Applicator
• Version Model Number: 309120-9020-000
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	04049539105523 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-22
• Device Publish Date: 2025-05-14

On-Brand Devices [INTRABEAM SMART Spherical Applicator ]

• 04049539105530: 309120-9025-000
• 04049539105523: 309120-9020-000
• 04049539105516: 309120-9015-00