UDI device identifier

MENTOR Tissue Expander 3505306M

UDI device identifier 00081317002598 · MENTOR TEXAS L.P.

Key facts

Primary DI 00081317002598
Brand name MENTOR Tissue Expander
Version or model 3505306M
Catalog number 350-5306M
Company MENTOR TEXAS L.P.
DUNS number 167450993
Product code LCJ
GMDN term Skin-port tissue expander
Premarket submission K842883
Device class Unclassified
Single use Yes
Packaged sterile Yes
Implantable Yes
Publish date Sep 14, 2015
Version date Mar 31, 2026
Description Smooth Eliptical, 125cc

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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