UDI device identifier
MEGA Ballast Distal Access Platform MEGABT09190
UDI device identifier 00840303711797 · BALT USA LLC
Key facts
| Primary DI | 00840303711797 |
|---|---|
| Brand name | MEGA Ballast Distal Access Platform |
| Version or model | MEGABT09190 |
| Company | BALT USA LLC |
| DUNS number | 945543689 |
| Product code | DQY |
| GMDN term | Vascular guide-catheter, single-use |
| Premarket submission | K242376 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Feb 19, 2025 |
| Version date | Aug 25, 2026 |
| Description | MEGA Ballast Distal Access Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No 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: