UDI device identifier

SKYN 0009

UDI device identifier 00070907000090 · SURETEX LIMITED - BRANCH

Key facts

Primary DI 00070907000090
Brand name SKYN
Version or model 0009
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 Jul 21, 2022
Version date Jul 29, 2022
Description SKYN ELITE 46CT

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)