UDI device identifier
POLARx™ FIT M004CRBS2060
UDI device identifier 08714729992622 · BOSTON SCIENTIFIC CORPORATION
Key facts
| Primary DI | 08714729992622 |
|---|---|
| Brand name | POLARx™ FIT |
| Version or model | M004CRBS2060 |
| Catalog number | M004CRBS2060 |
| Company | BOSTON SCIENTIFIC CORPORATION |
| DUNS number | 021717889 |
| Product code | OAE |
| GMDN term | Cardiac cryosurgical system catheter |
| Premarket submission | P220032 |
| Device class | Class III |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Aug 21, 2023 |
| Version date | Aug 29, 2023 |
| Description | Cryoablation Balloon Catheter |
At a glance
- 1–9 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: