UDI device identifier

LEADER 4938494

UDI device identifier 00096295125597 · Cardinal Health 110, Inc.

Key facts

Primary DI 00096295125597
Brand name LEADER
Version or model 4938494
Catalog number 4938494
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 May 10, 2022
Description LDR Unifine Pentips Plus Micro 32G x 4mm 100 pen needles

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:

Browse all UDI device identifiers (GUDID)