Duns Number:741172167
Device Description: The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bo The CardioCel 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
C0508
Brand Name
CardioCel Neo
Version/Model Number
UC0508N
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
K130872
Product Code
DXZ
Product Code Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Public Device Record Key
b1d266ad-0565-4453-8996-4ad82c948dc6
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
October 17, 2016
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 |