Cobra PzF

FDA UDI

Class III (US FDA UDI)

by Celonova Biosciences, Inc.

Identity

Trade Name: Cobra PzF FDA UDI
Generic Name: Bare-metal coronary artery stent FDA UDI
Device Name: NanoCoated Coronary Stent System FDA UDI
Model / Reference: 170-03-40024 FDA UDI
Description: NanoCoated Coronary Stent System FDA UDI

Identifiers

Catalog Number: 170-03-40024 FDA UDI
Primary DI / UDI-DI: 00879397000937 FDA UDI
PMA Number: P160014 FDA UDI
FDA Product Code: MAF FDA UDI
GMDN Term: Bare-metal coronary artery stent FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 24 Millimeter FDA UDI
Lumen/Inner Diameter — 4.00 Millimeter FDA UDI

Category: Bare-metal coronary artery stent

The Cobra PzF MRI Conditional bare-metal coronary artery stent is a dedicated disposable implantation device designed for symptomatic atherosclerotic heart disease. This non-bioabsorbable tubular device is intended to be implanted in a coronary artery or saphenous vein graft of the heart to maintain luminal patency and improve luminal diameter.

Similar devices

Also classified as Bare-metal coronary artery stent.

REBEL™ — Boston Scientific · Class III
Graftmaster — Abbott Vascular · Unclassified
Integrity — MEDTRONIC, INC. · Class III
Tryton Side Branch Stent — TRYTON MEDICAL, INC. · Class III
Integrity — MEDTRONIC, INC. · Class III
REBEL™ — Boston Scientific · Class III
REBEL™ — Boston Scientific · Class III
REBEL™ — Boston Scientific · Class III

Cleared under the same submission

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 III	Pending data

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Manufacturer

Manufacturer: Celonova Biosciences, Inc.

Sources (1)

FDA UDI a6be25b7-384e-4e09-b2c7-3945eb48f2cb 36 fields · synced Jul 30, 2026