UDI device identifier
Flo-Thru Intraluminal Shunt® FT-12175
UDI device identifier 00085412532462 · SYNOVIS LIFE TECHNOLOGIES, INC.
Key facts
| Primary DI | 00085412532462 |
|---|---|
| Brand name | Flo-Thru Intraluminal Shunt® |
| Version or model | FT-12175 |
| Catalog number | FT12175 |
| Company | SYNOVIS LIFE TECHNOLOGIES, INC. |
| DUNS number | 017415781 |
| Product code | DXC |
| GMDN term | Surgical intravascular shunt |
| Premarket submission | K981624 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Sep 24, 2016 |
| Version date | Jul 6, 2018 |
| Description | The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis. |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1,000+ GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: