UDI device identifier

SafeOp AIX1202A

UDI device identifier 00190376233970 · ALPHATEC SPINE, INC.

Key facts

Primary DI 00190376233970
Brand name SafeOp
Version or model AIX1202A
Company ALPHATEC SPINE, INC.
DUNS number 602465783
Product code GXY
GMDN term Transcutaneous electrical stimulation electrode, single-use
Premarket submission K182542
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Dec 31, 2019
Version date Feb 19, 2021
Description SafeOp EMG/NMJ Surface Electrode Procedure Kit

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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