pNOVUS 21 Microcatheter

FDA UDI

Class II (US FDA UDI)

by Phenox Limited

Identity

Trade Name: pNOVUS 21 Microcatheter FDA UDI
Generic Name: Vascular microcatheter FDA UDI
Device Name: 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. FDA UDI
Model / Reference: PNOV-21-160 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 05391530910132 FDA UDI
FDA Product Code: DQO FDA UDI
QJP FDA UDI
GMDN Term: Vascular microcatheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1200 FDA UDI
870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Vascular microcatheter

pNOVUS 21 Microcatheter by Phenox Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PROWLER — Medos International Sàrl · Class II
Merit Maestro® — Merit Medical Systems, Inc. · Class II
Lantern Delivery Catheter — PENUMBRA, INC. · Class II
Direxion™ Fathom™-16 System — Boston Scientific · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Phenox Limited

Sources (1)

FDA UDI a2b7c596-a7d1-457b-b329-f64e5bdce532 33 fields · synced May 30, 2026