Identity
- Trade Name
- Sundt™ FDA UDI
- Generic Name
- Carotid artery shunt FDA UDI
- Device Name
- Sundt™ Internal Carotid Endarterectomy Shunt FDA UDI
- Model / Reference
- NL8505065 FDA UDI
- Description
- Sundt™ Internal Carotid Endarterectomy Shunt FDA UDI
Identifiers
- Catalog Number
- NL8505065 FDA UDI
- Primary DI / UDI-DI
- 10381780026228 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Carotid artery shunt FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carotid artery shunt
Sundt™ by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carotid artery shunt.
- Pruitt F3 Carotid Shunt — LeMaitre Vascular, Inc. · Class II
- LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER — LUCAS MEDICAL INC · Class II
- LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER — LUCAS MEDICAL INC · Class II
- LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER — LUCAS MEDICAL INC · Class II
- CAROTID ENDARTERECTOMY SHUNT — LUCAS MEDICAL INC · Class II
- Pruitt F3 Carotid Shunt — LeMaitre Vascular, Inc. · Class II
- Pruitt F3 Carotid Shunt — LeMaitre Vascular, Inc. · Class II
- LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER — LUCAS MEDICAL INC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI e2177bc3-f835-43f9-82ff-136a339739ba 36 fields · synced May 30, 2026