UDI device identifier

ASSURE® ID Insulin 1cc Safety Syringe 210291

UDI device identifier 00015482102913 · Arkray USA, Inc.

Key facts

Primary DI 00015482102913
Brand name ASSURE® ID Insulin 1cc Safety Syringe
Version or model 210291
Company Arkray USA, Inc.
DUNS number 008171162
Product code FMI
GMDN term Metered-delivery hypodermic syringe/needle
Premarket submission K103011
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Sep 23, 2016
Version date Aug 24, 2026
Description Sterile Safety Syringe

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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