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
- 170-03-40012 FDA UDI
- Description
- NanoCoated Coronary Stent System FDA UDI
Identifiers
- Catalog Number
- 170-03-40012 FDA UDI
- Primary DI / UDI-DI
- 00879397000906 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Millimeter FDA UDILumen/Inner Diameter — 4.00 Millimeter FDA UDI
Category: Bare-metal coronary artery stent
Cobra PzF by Celonova Biosciences, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal coronary artery stent.
- REBEL™ — Boston Scientific · Class III
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- 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
P160014 also covers:
- Cobra PzF — Celonova Biosciences, Inc.
- Cobra PzF — Celonova Biosciences, Inc.
- Cobra PzF — Celonova Biosciences, Inc.
- Cobra PzF — Celonova Biosciences, Inc.
- Cobra PzF — Celonova Biosciences, Inc.
- Cobra PzF — Celonova Biosciences, Inc.
- Cobra PzF — Celonova Biosciences, Inc.
- Cobra PzF — Celonova Biosciences, Inc.
- Cobra PzF — Celonova Biosciences, Inc.
- Cobra PzF — Celonova Biosciences, Inc.
- Cobra PzF — Celonova Biosciences, Inc.
- Cobra PzF — Celonova Biosciences, Inc.
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 7f8535a7-62af-403a-83dd-de33bd7dbf59 36 fields · synced May 30, 2026