Refinity Rotational Intravascular Ultrasound IVUS Catheter

Basic Information

• Brand Name: Refinity Rotational Intravascular Ultrasound IVUS Catheter
• Primary DI: 00845225002824
• Version / Model: 89800
• Company Name: Volcarica S.R.L.
• Labeler DUNS: 853202646
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-09
• Public Version: 5
• Public Version Date: 2021-10-26
• Public Version Status: Update
• Public Device Record Key: 404a6c2c-94f0-4fb1-8a02-1a13eff0ca24

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	870.1200	2
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44141	Intravascular ultrasound imaging catheter, single-use	A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845225002824	GS1

Premarket Submissions

Submission Number	Supplement Number
K160583	000