UDI device identifier
R-100 804547001
UDI device identifier 00184360000327 · VOLCANO CORPORATION
Key facts
| Primary DI | 00184360000327 |
|---|---|
| Brand name | R-100 |
| Version or model | 804547001 |
| Catalog number | 804547001 |
| Company | VOLCANO CORPORATION |
| DUNS number | 135179237 |
| Product code | ITX |
| GMDN term | Intravascular ultrasound imaging catheter extractor, reusable |
| Premarket submission | K962293 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 12, 2016 |
| Version date | Jul 28, 2023 |
| Description | R-100 Pullback Device |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- Yes 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: