Duns Number:236510785
Catalog Number
PV0870
Brand Name
Spiral Flow Peripheral Vascular Graft
Version/Model Number
PV0870
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
DSY
Product Code Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Public Device Record Key
500904ec-5178-4604-9651-c622960c9fab
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
March 16, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |