AccessGUDID - DEVICE: Neuro-IOM (04650075330371)

GUDID

Device Identifier (DI) Information

Brand Name: Neuro-IOM
Version or Model: Neuro-IOM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEUROSOFT, OOO

Primary DI Number: 04650075330371
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 643212926 *Terms of Use

Device Description: Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient’s neurophysiological status. The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations: I. 32/B II. 32/S III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (au-ditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed. The system is not intended to measure the vital signs. It records the data to be inter-preted by the neuromonitoring specialist.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
46566	Neurophysiologic monitoring system	An assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWF	Stimulator, Electrical, Evoked Response
GWE	Stimulator, Photic, Evoked Response
GWJ	Stimulator, Auditory, Evoked Response
OLT	Non-Normalizing Quantitative Electroencephalograph Software
PDQ	Neurosurgical Nerve Locator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190703	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: a256d837-17f7-4ce4-abcc-dbd397246e01
Public Version Date: June 18, 2021
Public Version Number: 1
DI Record Publish Date: June 10, 2021