INTRABEAM Spherical Sizer Set

GUDID 04049539105509

The INTRABEAM Spherical Sizer Set is a sterile disposable product. It is intended to be used in the context of radiation therapy. It shall be used to assess which INTRABEAM SMART Spherical Applicator, or INTRABEAM Spherical Applicator, shall be used for the given radiation therapy treatment using INTRABEAM system, based on the dimensions of the treatment location (intracavitary or intraoperative). It shall be used only with an INTRABEAM device.

Carl Zeiss Meditec AG

Intraoperative/postoperative therapeutic x-ray system applicator sizer

• Primary Device ID: 04049539105509
• NIH Device Record Key: b91c9230-96b8-4c26-83b5-adcbcf7cfd5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRABEAM Spherical Sizer Set
• Version Model Number: 309121-9100-000
• 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: false
• Manufacturing Date: true
• 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	04049539105509 [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: 2025-06-30
• Device Publish Date: 2025-06-20

Devices Manufactured by Carl Zeiss Meditec AG

• 04049539105509 - INTRABEAM Spherical Sizer Set: 2025-06-30The INTRABEAM Spherical Sizer Set is a sterile disposable product. It is intended to be used in the context of radiation therapy. It shall be used to assess which INTRABEAM SMART Spherical Applicator, or INTRABEAM Spherical Applicator, shall be used for the given radiation therapy treatment using INTRABEAM system, based on the dimensions of the treatment location (intracavitary or intraoperative). It shall be used only with an INTRABEAM device.
• 04049539105509 - INTRABEAM Spherical Sizer Set: 2025-06-30 The INTRABEAM Spherical Sizer Set is a sterile disposable product. It is intended to be used in the context of radiation therap
• 04049539105516 - INTRABEAM SMART Spherical Applicator: 2025-05-22
• 04049539105523 - INTRABEAM SMART Spherical Applicator: 2025-05-22
• 04049539105530 - INTRABEAM SMART Spherical Applicator: 2025-05-22
• 04049539105547 - INTRABEAM SMART Spherical Applicator (35 mm): 2025-05-22
• 04049539105554 - INTRABEAM SMART Spherical Applicator (35mm): 2025-05-22
• 04049539105561 - INTRABEAM SMART Spherical Applicator (40mm): 2025-05-22
• 04049539105578 - INTRABEAM SMART Spherical Applicator (45mm): 2025-05-22