AccessGUDID - DEVICE: Auragen™ (10381780035091)

GUDID

Device Identifier (DI) Information

Brand Name: Auragen™
Version or Model: 40M63
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780035091
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.

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":	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 [?]
K082250	000
K926424	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
Special Storage Condition, Specify: Room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 101 platinum contacts

Device Record Status

Public Device Record Key: e10bcbec-1ae4-475a-840a-9de9e1224847
Public Version Date: March 18, 2024
Public Version Number: 4
DI Record Publish Date: August 08, 2016