UDI device identifier

Glean GUS-1000-F

UDI device identifier 00086000980061 · Bright Uro, Inc

Key facts

Primary DI 00086000980061
Brand name Glean
Version or model GUS-1000-F
Catalog number GUS-1000-F
Company Bright Uro, Inc
DUNS number 117955543
Product code EXQ
GMDN term Urodynamic manometric catheter, electronic, single-use
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Sep 23, 2025
Version date Oct 1, 2025
Description Glean Sensor with Female Insertion Tool 5 Pack

At a glance

  • None MAUDE reports citing this UDI
  • No Linked premarket submission
  • No EUDAMED counterpart found
  • 10–99 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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