AccessGUDID - DEVICE: NA (03664539004099)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: INTRAOPERATIVE SUBDURAL ELECTRODE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 302658-000
Company Name: DIXI MEDICAL

Primary DI Number: 03664539004099
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 268009609 *Terms of Use

Device Description: SUBDURAL ELECTRODE WITH CONNECTION CABLE, GRID, 4x4 CONTACTS

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":	Yes
For Single-Use:	Yes
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?
32545	Cortical electrode	A sterile, invasive, electrical conductor that is temporarily placed (< 30 days) on the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a series of discs mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The implanted device, also known as a subdural electrode, is connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GYC	Electrode, Cortical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201931	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Device Size Text, specify: Contact Exposure Diameter 4 Millimeters

Device Record Status

Public Device Record Key: 57b6b55f-101c-437e-b48f-d17d11d0e2fe
Public Version Date: October 01, 2024
Public Version Number: 1
DI Record Publish Date: September 23, 2024