Duns Number:081132841
Device Description: The Vein/Aorta Gauge is a product that will assess outside diameter and wall thickness of The Vein/Aorta Gauge is a product that will assess outside diameter and wall thickness of a graft conduit and the outside diameter of a target vessel for reference only.
Catalog Number
FG-000003
Brand Name
Cardica Vein/Aorta Gauge
Version/Model Number
FG-000003
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
-
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
29465ad3-be1c-42e1-8827-fb83b204d02c
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 19, 2019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |