Duns Number:041810693
Device Description: Aortic Punches are used to create a uniform opening in blood vessels during cardiovascular Aortic Punches are used to create a uniform opening in blood vessels during cardiovascular surgery. The vessel graft is inserted into the created opening and sutured to the vessel wall. Aortic Lancets are used to make a small uniform cut in a blood vessel to facilitate insertion of an aortic punch. Punches come in various lengths, diameters and tip configurations.
Catalog Number
RCL40
Brand Name
CleanCut Rotating Aortic Punch
Version/Model Number
RCL40
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
-
Product Code
DWS
Product Code Name
Instruments, Surgical, Cardiovascular
Public Device Record Key
64067912-463c-4e69-9d12-1763eaa0300e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 11, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 168 |
| U | Unclassified | 8 |