UDI device identifier
N-Dex XS
UDI device identifier 00038054686468 · SHOWA BEST GLOVE, INC.
Key facts
| Primary DI | 00038054686468 |
|---|---|
| Brand name | N-Dex |
| Version or model | XS |
| Catalog number | M7005PXS |
| Company | SHOWA BEST GLOVE, INC. |
| DUNS number | 807930412 |
| Product code | LZA |
| GMDN term | Nitrile examination/treatment glove, non-powdered, non-antimicrobial |
| Premarket submission | K211003 |
| Device class | Class I |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Feb 20, 2023 |
| Version date | Feb 28, 2023 |
| Description | Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/Extra small |
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: