UDI device identifier

Assure® ID Safety Pen Needles, 30G x 5mm Sample 10's 275030

UDI device identifier 00015482270308 · Arkray USA, Inc.

Key facts

Primary DI 00015482270308
Brand name Assure® ID Safety Pen Needles, 30G x 5mm Sample 10's
Version or model 275030
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 Jan 14, 2020
Version date Aug 24, 2026
Description Insulin Safety Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the safety shield automatically covers the needle to minimize the risk of accidental needle sticks.

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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