UDI device identifier

WINK CLOSER 14011

UDI device identifier 00028373140116 · OKAMOTO USA, INC.

Key facts

Primary DI 00028373140116
Brand name WINK CLOSER
Version or model 14011
Company OKAMOTO USA, INC.
DUNS number 175752724
Product code HIS
GMDN term Basic male condom, Hevea-latex
Premarket submission K243584
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Mar 11, 2026
Version date Mar 19, 2026
Description WINK Closer Condom (10ct box)

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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