UDI device identifier

ARKRAY Multi-let 2 Lancing Device 660016

UDI device identifier 00015482660161 · Arkray USA, Inc.

Key facts

Primary DI 00015482660161
Brand name ARKRAY Multi-let 2 Lancing Device
Version or model 660016
Company Arkray USA, Inc.
DUNS number 008171162
Product code QRL
GMDN term Manual blood lancing device, reusable
Premarket submission K221175
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Sep 24, 2018
Version date Aug 24, 2026
Description A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g…

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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