Duns Number:741172167
Device Description: CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Techn CardioCel® 3D 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 riskfor BSE.The device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in asolution of propylene glycol and sealed in a container impermeable to air and moisture.
Catalog Number
C0405A30
Brand Name
CardioCel 3D
Version/Model Number
UC0405A30
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
K170951
Product Code
PSQ
Product Code Name
Intracardiac Patch Or Pledget, Biologically Derived
Public Device Record Key
a6a92888-642e-488e-b8d7-4ca5902fd135
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
September 07, 2018
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 |