UDI device identifier

SafeOp 200578-SS

UDI device identifier 00190376192277 · ALPHATEC SPINE, INC.

Key facts

Primary DI 00190376192277
Brand name SafeOp
Version or model 200578-SS
Company ALPHATEC SPINE, INC.
DUNS number 602465783
Product code IKN
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 SafeOp Head Unit-A

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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