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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 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 16 Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 1.2 mm Humanitarian Device USA ONLY): Authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4mm. Wide-neck is defined as having a neck width greater than or equal to 4mm or a dome-to-neck ratio less than 2mm. The effectiveness of this device for this use has not been demonstrated. FDA UDI
Model / Reference
ENF401612 FDA UDI
Description
CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 16 Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 1.2 mm Humanitarian Device USA ONLY): Authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4mm. Wide-neck is defined as having a neck width greater than or equal to 4mm or a dome-to-neck ratio less than 2mm. The effectiveness of this device for this use has not been demonstrated. FDA UDI

Identifiers

Catalog Number
ENF401612 FDA UDI
Primary DI / UDI-DI
10886704075332 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
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

Category: Bare-metal intracranial vascular stent

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

Similar devices

Also classified as Bare-metal intracranial vascular stent.

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 2a3944ae-355a-423d-b24a-2e69aad65250 36 fields · synced May 31, 2026