UDI device identifier

MENTOR SILTEX CONTOUR PROFILE Moderate 3542915

UDI device identifier 00081317001898 · MENTOR TEXAS L.P.

Key facts

Primary DI 00081317001898
Brand name MENTOR SILTEX CONTOUR PROFILE Moderate
Version or model 3542915
Catalog number 354-2915
Company MENTOR TEXAS L.P.
DUNS number 167450993
Product code FWM
GMDN term Saline-filled breast implant, unstructured, textured-surface
Premarket submission P990075
Device class Class III
Single use Yes
Packaged sterile Yes
Implantable Yes
Publish date Sep 17, 2014
Version date Feb 11, 2021
Description Saline Breast Implant with Diaphragm Valve, 525cc

At a glance

  • 10–99 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)