UDI device identifier

LEADER, pen needles 32G x 4 mm

UDI device identifier 00096295138771 · HTL STREFA S A

Key facts

Primary DI 00096295138771
Brand name LEADER, pen needles
Version or model 32G x 4 mm
Catalog number 8471
Company HTL STREFA S A
DUNS number 422528088
Product code FMI
GMDN term Autoinjector needle
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Dec 19, 2019
Version date Aug 16, 2021
Description Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous injection of drugs.

At a glance

  • None MAUDE reports citing this UDI
  • No 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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