Duns Number:788403103
Device Description: The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an o The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
Catalog Number
-
Brand Name
IBC Aortic Punch, Medium, 3.6mm
Version/Model Number
APM36
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 13, 2021
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
ad71b1ea-57db-4e46-9ca9-673ebc81babd
Public Version Date
December 14, 2021
Public Version Number
3
DI Record Publish Date
August 02, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |