UDI device identifier

Skyn 9318

UDI device identifier 00070907293188 · SURETEX LIMITED - BRANCH

Key facts

Primary DI 00070907293188
Brand name Skyn
Version or model 9318
Company SURETEX LIMITED - BRANCH
DUNS number 672044515
Product code MOL
GMDN term Basic male condom, synthetic polymer
Premarket submission K171172
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Dec 20, 2018
Version date Jul 22, 2022
Description SKYN COCKTAIL CLUB 10CT (CHERRY SUNRISE, PASSION DAIQUIRI, PINA COLADA)

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 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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