Duns Number:083171244
Device Description: SUNDT EXT. CAROTID ENDARTER SHU.The Integra Sundt external carotid endartecrectomy shunt i SUNDT EXT. CAROTID ENDARTER SHU.The Integra Sundt external carotid endartecrectomy shunt is designed to provide temporary carotid bypass for cerebral circulation during carotid endarterectomy procedures. The shunts are constructed of silicone elastomer with stainless steel spring reinforcement to minimize kinking and occlusion of the cannula lumen and to aid in the ease of insertion of the proximal and distal ends. The ends of the shunts have cone-shaped bulbs to facilitate fixation of the shunt in the vessel.
Catalog Number
NL81064S01
Brand Name
Sundt™
Version/Model Number
NL81064S01
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
fd276263-cbe7-48ac-91a4-2fb07418fe07
Public Version Date
September 22, 2020
Public Version Number
4
DI Record Publish Date
September 22, 2015
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 |