UDI device identifier

SafeOp 200507-SS

UDI device identifier 00190376180342 · ALPHATEC SPINE, INC.

Key facts

Primary DI 00190376180342
Brand name SafeOp
Version or model 200507-SS
Company ALPHATEC SPINE, INC.
DUNS number 602465783
Product code ETN
GMDN term Neurophysiologic monitoring system
Premarket submission K182542
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Dec 31, 2019
Version date Jan 8, 2020
Description AIX Tablet

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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