ARCADIS Avantic

Basic Information

• Brand Name: ARCADIS Avantic
• Primary DI: 04056869009001
• Version / Model: 10143408
• Company Name: Siemens Healthcare GmbH
• Labeler DUNS: 313217003
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 54796ca9-4756-4934-b703-d5e5f0c0b974

Device Description

mobile C-arm

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: 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
OXO	Image-intensified fluoroscopic x-ray system, mobile	Radiology	892.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37631	Portable general-purpose fluoroscopic x-ray system, analogue	An assembly of devices that comprise a portable (moved from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time analogue or analogue-to-digital techniques for image capture, display and manipulation used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested/injected x-ray contrast medium.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04056869009001	GS1

Customer Contacts

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