Duns Number:741172167
Device Description: CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technolo CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk for BSE.The device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in a solution of propylene glycol and sealed in a container impermeable to air and moisture.
Catalog Number
C0202
Brand Name
CardioCel Cardiovascular Patch
Version/Model Number
UC0202
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
fc3d22a5-b847-4ddd-b5e4-db46fabccdf1
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 |