Circular Small Field Cone Insert, Varian, 35mm

Basic Information

• Brand Name: Circular Small Field Cone Insert, Varian, 35mm
• Primary DI: B36550366350
• Version / Model: 50-366-35
• Company Name: Aktina Corp.
• Labeler DUNS: 787178920
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-24
• Public Version: 1
• Public Version Date: 2021-06-01
• Public Version Status: New
• Public Device Record Key: cd59f905-45d5-404a-8c8f-e4f6d3ea307f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42263	Fixed-aperture therapeutic x-ray system collimator	A non-automated, x-ray beam-limiting device that is a component of a therapeutic x-ray system and whose opening size/length/shutter assembly is fixed. It is used in radiation therapy applications to limit the effects of scattered radiation and to protect the patient by limiting or eliminating exposure to non-target body areas during treatment. This device is specifically designed for use with an x-ray simulation or therapeutic x-ray system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B36550366350	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K161984	000