UDI device identifier

LEADER 4490819

UDI device identifier 00096295120905 · Cardinal Health 110, Inc.

Key facts

Primary DI 00096295120905
Brand name LEADER
Version or model 4490819
Catalog number 4490819
Company Cardinal Health 110, Inc.
DUNS number 063997360
Product code FMI
GMDN term Autoinjector needle
Premarket submission K152339
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Jul 7, 2017
Version date Aug 7, 2025
Description LDR Unifine Pentips Plus Short 31G x 8mm 100 pen needles

At a glance

  • None 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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