Duns Number:741172167
Device Description: The VascuCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bov The VascuCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet of acellular collagen.
Catalog Number
V0880
Brand Name
VascuCel Vascular Patch
Version/Model Number
UV0880
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K162579
Product Code
DXZ
Product Code Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Public Device Record Key
56ab514b-cfea-4b95-8c28-5f412fcd19d7
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
April 16, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |