UDI device identifier

SKYN 0207

UDI device identifier 00070907202074 · SURETEX LIMITED - BRANCH

Key facts

Primary DI 00070907202074
Brand name SKYN
Version or model 0207
Company SURETEX LIMITED - BRANCH
DUNS number 672044515
Product code MOL
GMDN term Basic male condom, synthetic polymer
Premarket submission K160399
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Aug 29, 2019
Version date Sep 6, 2019
Description SKYN SELECTION 12CT (CONTAINS SKYN ORIGINAL, SKYN EXTRA STUDDED, SKYN ELITE EXTRA LUBE, SKYN ELITE)

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:

Browse all UDI device identifiers (GUDID)