UDI device identifier
Flo-Rester® Disposable Internal Vessel Occluder 50400
UDI device identifier 00085412532004 · SYNOVIS LIFE TECHNOLOGIES, INC.
Key facts
| Primary DI | 00085412532004 |
|---|---|
| Brand name | Flo-Rester® Disposable Internal Vessel Occluder |
| Version or model | 50400 |
| Catalog number | 50400 |
| Company | SYNOVIS LIFE TECHNOLOGIES, INC. |
| DUNS number | 017415781 |
| Product code | DXC |
| GMDN term | Intravascular anastomosis occluder |
| Premarket submission | K883696 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Sep 24, 2016 |
| Version date | Feb 19, 2021 |
| Description | Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs on the distal ends of a flexible shaft. A tab on a tether is attached to the midpoint of the flexible shaft forming a T configuration. Flo-Rester bulbs and tab are radiopaque. |
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: