Duns Number:482661753
Device Description: CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Sten CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4.5mm Unconstrained Stent Length 14mm. 12mm Distal tip. Maximum Stent foreshortening 1.1mm, Recommended Microcatheter .021inch(0.533mm)
Catalog Number
ENF451412
Brand Name
CERENOVUS ENTERPRISE
Version/Model Number
ENF451412
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 30, 2019
Issuing Agency
In GS1
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
NJE
Product Code Name
intracranial neurovascular stent
Public Device Record Key
36e2719f-929c-4897-8104-0498483eb863
Public Version Date
October 12, 2021
Public Version Number
6
DI Record Publish Date
September 20, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |