UDI device identifier

Assure® ID Safety Pen Needle 5mm x 31g 100's 275131

UDI device identifier 00015482275310 · Arkray USA, Inc.

Key facts

Primary DI 00015482275310
Brand name Assure® ID Safety Pen Needle 5mm x 31g 100's
Version or model 275131
Company Arkray USA, Inc.
DUNS number 008171162
Product code FMI
GMDN term Autoinjector needle
Premarket submission K161950
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Mar 8, 2018
Version date Aug 24, 2026
Description Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.

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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