Duns Number:121170653
Device Description: Vein graft cannula, blunt tip with check valve
Catalog Number
213-026
Brand Name
Surge Cardiovascular
Version/Model Number
213-026
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
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
050c89d8-cb6b-48d3-a9ec-8c34c1acb5d2
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10817278010146
Quantity per Package
25
Contains DI Package
00817278010149
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |