Home GUDID 05391530910132 pNOVUS 21 Microcatheter
Primary DI 05391530910132
Brand pNOVUS 21 Microcatheter
Company PHENOX LIMITED
Model PNOV-21-160
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.
Published 2023-01-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name DQO Catheter, Intravascular, Diagnostic QJP Catheter, Percutaneous, Neurovasculature
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQO Catheter, Intravascular, Diagnostic Cardiovascular 2 QJP Catheter, Percutaneous, Neurovasculature Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391530910132 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391530910132 05391530910132 5391530910132
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 985621869 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05391530910231 Esperance pHLO Aspiration System PHLO-AC-71-125 2026-02-10 05391530910248 Esperance pHLO Aspiration System PHLO-AC-71-135 2026-02-10 05391530910460 pRESET® Delta Thrombectomy Device (6mm x 30mm) PRE2-6-30 2025-03-03 05391530910477 pRESET® Delta Thrombectomy Device (4mm x 20mm) PRE2-4-20 2025-03-03 05391530910484 pRESET® Delta Thrombectomy Device (5mm x 40mm) PRE2-5-40 2025-03-03 05391530910491 pRESET® Delta LITE Thrombectomy Device (3mm x 20mm) PRE2-LT-3-20 2025-03-03 05391530910507 pRESET® Delta LITE Thrombectomy Device (4mm x 20mm) PRE2-LT-4-20 2025-03-03 05391530910378 pNOVUS 21 Microcatheter (150cm) PNOV-21-150 2024-12-02 05391530910392 pNOVUS 21 Microcatheter (160cm) PNOV-21-160 2024-12-02 05391530910095 pRESET® LITE Thrombectomy Device (3mm x 20mm) PRE-LT-3-20 2023-11-13 05391530910101 pRESET® LITE Thrombectomy Device (4mm x 20mm) PRE-LT-4-20 2023-11-13 05391530910002 pRESET® Thrombectomy Device (4mm x 20mm) PRE-4-20 2023-01-24 05391530910019 pRESET® Thrombectomy Device (6mm x 30mm) PRE-6-30 2023-01-24 05391530910125 pRESET® Thrombectomy Device (5mm x 40mm) PRE-5-40 2023-01-24 05391530910040 pORTAL® Steerable Hydrophilic Guidewire PORT-14-200-1 2020-02-06 05391530910057 pORTAL® EXT Extension Wire PORT-14-115-1-EX 2020-02-06
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