UDI device identifier

TRUEplus TRUEplus Sterile Pen Needles

UDI device identifier 00021292010300 · TRIVIDIA HEALTH, INC.

Key facts

Primary DI 00021292010300
Brand name TRUEplus
Version or model TRUEplus Sterile Pen Needles
Catalog number S5H01D31-050
Company TRIVIDIA HEALTH, INC.
DUNS number 151810868
Product code FMI
GMDN term Autoinjector needle
Premarket submission K143437
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Jul 22, 2017
Version date Jul 6, 2018
Description TRUEplus Pen Needles 31G x 5/16"

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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