UDI device identifier

Arcus 16122-02

UDI device identifier 00190376215884 · ALPHATEC SPINE, INC.

Key facts

Primary DI 00190376215884
Brand name Arcus
Version or model 16122-02
Company ALPHATEC SPINE, INC.
DUNS number 602465783
Product code PDQ
GMDN term Neurophysiologic monitoring system
Premarket submission K191723
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Dec 1, 2019
Version date Dec 9, 2019
Description Arcus Stimulating Targeting Needle, Bevel Tip

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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