AccessGUDID - DEVICE: NeuroOmega System (07290014954007)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroOmega System
Version or Model: Neuro Omega System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NOM-000000-00
Company Name: ALPHA OMEGA ENGINEERING CO. LTD.

Primary DI Number: 07290014954007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531856466 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11474	Electromyograph	An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.	Active	false
32568	Neurological stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKN	Electromyograph, Diagnostic
GWQ	Full-Montage Standard Electroencephalograph
GWF	Stimulator, Electrical, Evoked Response
GZL	Electrode, Depth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123796	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bb82ff31-b47b-4c54-a047-259d64dad05c
Public Version Date: November 28, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016