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
CodeName
DQOCatheter, Intravascular, Diagnostic
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530910132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530910132053915309101325391530910132

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA 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 DIBrandModelCatalogPublished
05391530910231Esperance pHLO Aspiration SystemPHLO-AC-71-1252026-02-10
05391530910248Esperance pHLO Aspiration SystemPHLO-AC-71-1352026-02-10
05391530910460pRESET® Delta Thrombectomy Device (6mm x 30mm)PRE2-6-302025-03-03
05391530910477pRESET® Delta Thrombectomy Device (4mm x 20mm)PRE2-4-202025-03-03
05391530910484pRESET® Delta Thrombectomy Device (5mm x 40mm)PRE2-5-402025-03-03
05391530910491pRESET® Delta LITE Thrombectomy Device (3mm x 20mm)PRE2-LT-3-202025-03-03
05391530910507pRESET® Delta LITE Thrombectomy Device (4mm x 20mm)PRE2-LT-4-202025-03-03
05391530910378pNOVUS 21 Microcatheter (150cm)PNOV-21-1502024-12-02
05391530910392pNOVUS 21 Microcatheter (160cm)PNOV-21-1602024-12-02
05391530910095pRESET® LITE Thrombectomy Device (3mm x 20mm)PRE-LT-3-202023-11-13
05391530910101pRESET® LITE Thrombectomy Device (4mm x 20mm)PRE-LT-4-202023-11-13
05391530910002pRESET® Thrombectomy Device (4mm x 20mm)PRE-4-202023-01-24
05391530910019pRESET® Thrombectomy Device (6mm x 30mm)PRE-6-302023-01-24
05391530910125pRESET® Thrombectomy Device (5mm x 40mm)PRE-5-402023-01-24
05391530910040pORTAL® Steerable Hydrophilic GuidewirePORT-14-200-12020-02-06
05391530910057pORTAL® EXT Extension WirePORT-14-115-1-EX2020-02-06

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