Duns Number:097462979
Device Description: Retrograde Cardioplegia Cannula, Self-Inflating text med balloon, Sure Touch Handle, 12.5" Retrograde Cardioplegia Cannula, Self-Inflating text med balloon, Sure Touch Handle, 12.5" length, 15Fr
Catalog Number
RSH-T014S-L
Brand Name
Surge Cardiovascular
Version/Model Number
RSH-T014S-L
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
ba908356-d43e-4aae-8140-f300fd78701a
Public Version Date
September 21, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
10817278011556
Quantity per Package
5
Contains DI Package
00817278011559
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 91 |