UDI device identifier
SET Rotarex™S 8 F x 110 cm 80239
UDI device identifier 07640142811886 · Straub Medical AG
Key facts
| Primary DI | 07640142811886 |
|---|---|
| Brand name | SET Rotarex™S 8 F x 110 cm |
| Version or model | 80239 |
| Catalog number | 80239 |
| Company | Straub Medical AG |
| DUNS number | 488489766 |
| Product code | MCW |
| GMDN term | Mechanical atherectomy system catheter/handpiece |
| Premarket submission | K172315 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | May 4, 2022 |
| Version date | Aug 17, 2026 |
| Description | Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex™S catheter (gauge 8F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag. |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 100–999 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: