UDI device identifier

Kimono MAXX Large Flare

UDI device identifier 00016169030246 · MAYER LABORATORIES, INC.

Key facts

Primary DI 00016169030246
Brand name Kimono
Version or model MAXX Large Flare
Catalog number 03024
Company MAYER LABORATORIES, INC.
DUNS number 175425982
Product code HIS
GMDN term Basic male condom, Hevea-latex
Premarket submission K941258
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Sep 15, 2016
Version date Jul 6, 2018
Description Latex Condom 24-ct

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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