Brachytherapy C-Arm Table-810, 230V

Basic Information

• Brand Name: Brachytherapy C-Arm Table-810, 230V
• Primary DI: 00879942070590
• Version / Model: 058-815
• Catalog Number: 058-815
• Company Name: Mirion Technologies (capintec), Inc.
• Labeler DUNS: 047684501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-26
• Public Version: 1
• Public Version Date: 2023-07-04
• Public Version Status: New
• Public Device Record Key: e03369ab-f2e2-46d1-95e6-cbbd21f274d0

Device Description

The Brachytherapy C-Arm Table 810 includes a radiolucent extension that provides capability for brachytherapy treatment involving the upper body and general C-Arm applications. The tabletop is cantilevered to accommodate portable or ceiling-suspended C-Arms and the wider front leg stance offers optimal patient access. The table controller adjusts height, X-Y, lateral roll and Trendelenburg motions of the tabletop.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40658	Fluoroscopy/angiography table, powered	A powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00879942070590	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]