Model: 1
DI: 07290018971017
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c6babcca-b6b3-4b8f-8881-f675d512f6b5
Distribution Status:
In Commercial Distribution
DUNS Number:
600237370
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07290018971017
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 11614
Name: Evoked-potential graphic recording system
Definition:
An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.
FDA Product Codes
SFN
Non-Invasive Evoked Response Brain Stimulator
Premarket Submissions
Submission Number:
DEN250002
Supplement Number:
000