UDI device identifier

ARTOURA Breast Tissue Expander SMXP100RH

UDI device identifier 00081317024286 · MENTOR TEXAS L.P.

Key facts

Primary DI 00081317024286
Brand name ARTOURA Breast Tissue Expander
Version or model SMXP100RH
Catalog number SMXP100RH
Company MENTOR TEXAS L.P.
DUNS number 167450993
Product code LCJ
GMDN term Skin-port tissue expander
Premarket submission K161176
Device class Unclassified
Single use Yes
Packaged sterile Yes
Implantable Yes
Publish date Jul 1, 2016
Version date Mar 31, 2026
Description Smooth, High Profile, Suture Tabs, Integral Injection Dome, 225cc

At a glance

  • 1–9 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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