UDI device identifier
ViziShot 2 FLEX NA-U403SX-4019
UDI device identifier 00821925043060 · Gyrus ACMI, LLC
Key facts
| Primary DI | 00821925043060 |
|---|---|
| Brand name | ViziShot 2 FLEX |
| Version or model | NA-U403SX-4019 |
| Company | Gyrus ACMI, LLC |
| DUNS number | 007198742 |
| Product code | KTI |
| GMDN term | Body aspiration needle, single-use |
| Premarket submission | K163469 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Sep 23, 2020 |
| Version date | Jun 13, 2025 |
| Description | SINGLE USE ASPIRATION NEEDLE |
At a glance
- 100–999 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: