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Cerenovus Enterprise

FDA UDI

Class Unclassified (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name
CERENOVUS ENTERPRISE FDA UDI
Generic Name
Bare-metal intracranial vascular stent FDA UDI
Device Name
CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4.5mm Unconstrained Stent Length 14mm No Distal tip. Maximum Stent foreshortening 1.1mm, Recommended Microcatheter .021inch(0.533mm) FDA UDI
Model / Reference
ENF451400 FDA UDI
Description
CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4.5mm Unconstrained Stent Length 14mm No Distal tip. Maximum Stent foreshortening 1.1mm, Recommended Microcatheter .021inch(0.533mm) FDA UDI

Identifiers

Catalog Number
ENF451400 FDA UDI
Primary DI / UDI-DI
10886704071747 FDA UDI
PMA Number
H060001 FDA UDI
FDA Product Code
NJE FDA UDI
GMDN Term
Bare-metal intracranial vascular stent FDA UDI

Classification

Device Class
Unclassified FDA UDI
Commercial Distribution
Not 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
MRI Safety
MR Conditional FDA UDI

Cerenovus Enterprise by Medos International Sàrl — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

H060001 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medos International Sàrl

Sources (1)

  • FDA UDI 4d96a4f6-15bf-4b7c-89c2-6fba0fc06182 38 fields · synced Jun 1, 2026