UDI device identifier
OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro 012-127
UDI device identifier 00057565121275 · A.M.G. Médicale Inc
Key facts
| Primary DI | 00057565121275 |
|---|---|
| Brand name | OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro |
| Version or model | 012-127 |
| 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 | Sep 15, 2020 |
| Version date | Sep 23, 2020 |
| Description | Customer focused packaging with 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 Comfortable fit Latex-free and powder-free for low… |
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: