UDI device identifier
Azurion Azurion 7 B12
UDI device identifier 00884838085350 · Philips Medical Systems Nederland B.V.
Key facts
| Primary DI | 00884838085350 |
|---|---|
| Brand name | Azurion |
| Version or model | Azurion 7 B12 |
| Catalog number | 722067 |
| Company | Philips Medical Systems Nederland B.V. |
| DUNS number | 413819707 |
| Product code | OWB |
| GMDN term | Stationary angiographic x-ray system, digital |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Dec 4, 2017 |
| Version date | Dec 15, 2025 |
| Description | Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ceiling-mounted lateral stand (12-inch flat detector) and optional interface for an OR table. |
At a glance
- 10–99 MAUDE reports citing this UDI
- No Linked premarket submission
- Yes 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: