UDI device identifier

Assure® ID INSULIN SAFETY SYRINGE 1mL 31G x 6mm 253311

UDI device identifier 00015482253110 · Arkray USA, Inc.

Key facts

Primary DI 00015482253110
Brand name Assure® ID INSULIN SAFETY SYRINGE 1mL 31G x 6mm
Version or model 253311
Company Arkray USA, Inc.
DUNS number 008171162
Product code MEG
GMDN term Metered-delivery hypodermic syringe/needle
Premarket submission K132681
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date May 26, 2020
Version date Aug 24, 2026
Description Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 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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