Sundt™
Sundt™ Internal Carotid Endarterectomy Shunt
3manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Integra Lifesciences Corporation, United States |
|---|---|
| FDA product code | DWF |
| Device type | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4210 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-06-20 |
| Record revised | 2023-05-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NL8505060 | 3mm x 4mm; Distal Tubing: 1mm I.D x 3mm O.D.; Proximal Tubing: 2mm x 4mm O.D.; Total Length: 10cm | In distribution |
| NL8505065 | 3mm x 4mm; Distal Tubing: 1mm I.D x 3mm O.D.; Proximal Tubing: 2mm x 4mm O.D.; Total Length: 10cm | In distribution |
| NL8505079 | 3.5mm x 4mm; Distal Tubing: 2mm I.D x 3.5mm O.D.; Proximal Tubing: 2mm x 4mm O.D.; Total Length: 30cm | In distribution |
| NL8505078 | 4mm x 5mm; Distal Tubing: 2mm I.D x 4mm O.D.; Proximal Tubing: 3mm x 5mm O.D.; Total Length: 30cm | In distribution |
| NL8505067 | 4mm x 5mm; Distal Tubing: 2mm I.D x 4mm O.D.; Proximal Tubing: 3mm x 5mm O.D.; Total Length: 10cm | In distribution |
| NL8505077 | 3.5mm x 5mm; Distal Tubing: 2mm I.D x 3.5mm O.D.; Proximal Tubing: 3mm x 5mm O.D.; Total Length: 30cm | In distribution |
| NL8505063 | 3.5mm x 4mm; Distal Tubing: 2mm I.D x 3.5mm O.D.; Proximal Tubing: 2mm x 4mm O.D.; Total Length: 10cm | In distribution |
| NL8505066 | 3mm x 5mm; Distal Tubing: 2mm I.D x 3mm O.D.; Proximal Tubing: 3mm x 5mm O.D.; Total Length: 10cm | In distribution |
| NL8505072 | 4mm x 5mm; Distal Tubing: 2mm I.D x 4mm O.D.; Proximal Tubing: 3mm x 5mm O.D.; Total Length: 30cm | In distribution |
| NL8505076 | 3mm x 4mm; Distal Tubing: 1mm I.D x 3mm O.D.; Proximal Tubing: 2mm x 4mm O.D.; Total Length: 30cm | In distribution |
| NL8505062 | 4mm x 5mm; Distal Tubing: 2mm I.D x 4mm O.D.; Proximal Tubing: 3mm x 5mm O.D.; Total Length: 10cm | In distribution |
| NL8505071 | 3mm x 5mm; Distal Tubing: 2mm I.D x 3mm O.D.; Proximal Tubing: 3mm x 5mm O.D.; Total Length: 30cm | In distribution |
| NL8505061 | 3.5mm x 5mm; Distal Tubing: 2mm I.D x 3.5mm O.D.; Proximal Tubing: 2mm x 5mm O.D.; Total Length: 10cm | In distribution |
| NL8505070 | 3mm x 4mm; Distal Tubing: 1mm I.D x 3mm O.D.; Proximal Tubing: 2mm x 4mm O.D.; Total Length: 30cm | In distribution |
| NL81064S01 | Outer diameter: 2.7mm x 5mm; Distal Tubin: 1mm I.D. x 2.7mm O.D.; Proximal Tubing: 3mm I.D. x 5mm O.D.; Total Length: 30cm (All dimensions nominal) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic, Inc. | 5,237 |
| DLP™ | Medtronic, Inc. | 804 |
| Bio-Medicus™ | Medtronic, Inc. | 223 |
| Pemco Inc | Pemco, Inc. | 137 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Maquet Cardiopulmonary GmbH | 135 |
| Venous cardiopulmonary bypass cannula | LivaNova USA, Inc. | 97 |
| Eopa™ | Medtronic, Inc. | 87 |
| Surge Cardiovascular | MED Michigan Holdings LLC | 80 |
| Arterial cardiopulmonary bypass cannula | LivaNova USA, Inc. | 79 |
| MC2™ | Medtronic, Inc. | 66 |
| Select Series® | Medtronic, Inc. | 63 |
| Edwards Lifesciences Aortic Perfusion Cannula | Edwards Lifesciences Technology Sarl | 52 |
Showing 12 of 372. All products under Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.