UDI device identifier
OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves 012-097
UDI device identifier 00057565120971 · A.M.G. Médicale Inc
Key facts
| Primary DI | 00057565120971 |
|---|---|
| Brand name | OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves |
| Version or model | 012-097 |
| Company | A.M.G. Médicale Inc |
| DUNS number | 207372814 |
| Product code | LZA |
| GMDN term | Nitrile examination/treatment glove, non-powdered, non-antimicrobial |
| Premarket submission | K110981 |
| Device class | Class I |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Mar 5, 2020 |
| Version date | Aug 21, 2020 |
| Description | Blue, Extra Small Packed: 100 / Box, 10 boxes / case Customer focused packaging Attractive, easy to read boxes Flexible packaging allowing vertical or horizontal merchandising increasing shop-ability while reducing shelf and storage space Ergonomic opening to avoid waste Recyclable packaging… |
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: