Duns Number:083171244
Device Description: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loop and used to provide temporary carotid bypass for cerebral circulation during carotid endartectomy procedures.
Catalog Number
NL8505079
Brand Name
Sundt™
Version/Model Number
NL8505079
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
83d78ecc-b1b6-4759-93d7-0f8cd6040fc7
Public Version Date
October 03, 2022
Public Version Number
4
DI Record Publish Date
June 20, 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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |