CERENOVUS ENTERPRISE - CERENOVUS ENTERPRISE 2 Vascular Reconstruction - Medos International Sàrl

Duns Number:482661753

Device Description: CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 39 Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 4.3 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.

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More Product Details

Catalog Number

ENF403912

Brand Name

CERENOVUS ENTERPRISE

Version/Model Number

ENF403912

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

H060001

Product Code Details

Product Code

NJE

Product Code Name

intracranial neurovascular stent

Device Record Status

Public Device Record Key

c2553787-4c77-4b67-bd73-4f66846f1de0

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

November 18, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDOS INTERNATIONAL SÀRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 972
2 A medical device with a moderate to high risk that requires special controls. 6382
3 A medical device with high risk that requires premarket approval 20
U Unclassified 20