INTRABEAM SMART Spherical Applicator

Basic Information

• Brand Name: INTRABEAM SMART Spherical Applicator
• Primary DI: 04049539105523
• Version / Model: 309120-9020-000
• Company Name: Carl Zeiss Meditec AG
• Labeler DUNS: 342228620
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-14
• Public Version: 1
• Public Version Date: 2025-05-22
• Public Version Status: New
• Public Device Record Key: 96980476-dbf1-4b35-b23c-f1825a470681

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAD	System, Therapeutic, X-Ray	Radiology	892.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67514	Intraoperative/postoperative therapeutic x-ray system spherical applicator, single-use	A component of an intraoperative/postoperative therapeutic x-ray system designed to be attached to and cover the x-ray source for direct patient contact when the system is used in the treatment of certain clinical conditions (e.g., breast cancer). It has a ball-shaped distal end that is typically inserted into a resected tumour bed for the irradiation of the tumour bed and/or margins during an operation. It may be supplied as a set of graduated sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049539105523	GS1

Premarket Submissions

Submission Number	Supplement Number
K241174	000