UDI device identifier

OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro 012-107

UDI device identifier 00057565121077 · A.M.G. Médicale Inc

Key facts

Primary DI 00057565121077
Brand name OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro
Version or model 012-107
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 20, 2020
Description Blue, 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 Comfortable…

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:

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