UDI device identifier

MAXX Large Flare Kimono MAXX

UDI device identifier 00016169030130 · MAYER LABORATORIES, INC.

Key facts

Primary DI 00016169030130
Brand name MAXX Large Flare
Version or model Kimono MAXX
Catalog number 03013
Company MAYER LABORATORIES, INC.
DUNS number 175425982
Product code HIS
GMDN term Basic male condom, Hevea-latex
Premarket submission K946376
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Oct 6, 2025
Version date Oct 14, 2025
Description Latex Condoms 1000 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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