UDI device identifier
Gel-One® Cross-linked Hyaluronate 00-1111-001-00
UDI device identifier 00087541300912 · SEIKAGAKU CORPORATION
Key facts
| Primary DI | 00087541300912 |
|---|---|
| Brand name | Gel-One® Cross-linked Hyaluronate |
| Version or model | 00-1111-001-00 |
| Catalog number | 00-1111-001-00 |
| Company | SEIKAGAKU CORPORATION |
| DUNS number | 690584057 |
| Product code | MOZ |
| GMDN term | Synovial fluid supplementation medium |
| Premarket submission | P080020 |
| Device class | Class III |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | Yes |
| Publish date | Sep 17, 2014 |
| Version date | Mar 22, 2021 |
| Description | Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is… |
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: