pNOVUS 21 Microcatheter

Basic Information

• Brand Name: pNOVUS 21 Microcatheter
• Primary DI: 05391530910132
• Version / Model: PNOV-21-160
• Company Name: PHENOX LIMITED
• Labeler DUNS: 985621869
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-09
• Public Version: 1
• Public Version Date: 2023-01-17
• Public Version Status: New
• Public Device Record Key: a2b7c596-a7d1-457b-b329-f64e5bdce532

Device Description

The pNOVUS 21 Microcatheter is intended for delivering diagnostic agents (such as contrast media), therapeutic agents (such as antiplatelet or vasodilating drugs) and non-liquid interventional devices (such as thrombectomy devices) to intra- and extracranial brain-supplying arteries and intra- and extracranial brain-draining veins. pNOVUS 21 is generally inserted either through a sheath or guide-catheter. Arterial access is typically gained in the femoral, brachial, or radial artery but other access sites (e.g. carotid artery) may be used in rare occasions. Most common sites for venous access are the femoral, brachial, basilic or cephalic vein, but other accessible veins may be used depending on the condition to be treated.

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: No
• 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
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	870.1200	2
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10691	Vascular microcatheter	A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391530910132	GS1