UDI device identifier
SET Rotarex™S 6 F x 135 cm 80237
UDI device identifier 07640142811862 · Straub Medical AG
Key facts
| Primary DI | 07640142811862 |
|---|---|
| Brand name | SET Rotarex™S 6 F x 135 cm |
| Version or model | 80237 |
| Catalog number | 80237 |
| 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 18, 2026 |
| Description | Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex™S catheter (gauge 6F; length 135 cm), one guidewire (0.018” diameter; 320 cm in length), one sterile 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: