FDA.reportPublic FDA data

NA

Primary DI
03664539003801
Brand
NA
Company
DIXI MEDICAL
Model
INTRAOPERATIVE SUBDURAL ELECTRODE
Catalog number
C10-06BIOM
Device description
SUBDURAL ELECTRODE WITH CONNECTION CABLE, STRIP, 1x6 CONTACTS
Published
2022-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GYCElectrode, Cortical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYCElectrode, CorticalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201931000Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)Dixi Medical2021-10-02GYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664539003801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664539003801036645390038013664539003801

GMDN Terms#

Term, Definition table
TermDefinition
Cortical electrodeA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33381889890info@diximedical.com

Regulatory Flags#

DUNS number
268009609
Device count
1
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664539002217NAEXTENSION CABLEPCP-18/902017-12-14
03664539002231NAEXTENSION CABLEPCP-18/3002017-12-14
03664539004365NAMICRODEEP DEPTH ELECTRODED08-15PIX2026-01-14
03664539004372NAMICRODEEP DEPTH ELECTRODED08-18PIX2026-01-14
03664539004174NAMICRO MACRO ELECTRODEMM08-08L27D082025-11-06
03664539004181NAMICRO MACRO ELECTRODEMM08-08L27E082025-11-06
03664539004198NAMICRO MACRO ELECTRODEMM08-08L27F082025-11-06
03664539004204NAMICRO MACRO ELECTRODEMM08-08L27G082025-11-06
03664539004211NAMICRO MACRO ELECTRODEMM08-08L27H082025-11-06
03664539004228NAMICRO MACRO ELECTRODEMM08-08L27I082025-11-06
03664539004235NAMICRO MACRO ELECTRODEMM08-08L27P082025-11-06
03664539004242NAMICRO MACRO ELECTRODEMM08-12L41D082025-11-06
03664539004259NAMICRO MACRO ELECTRODEMM08-12L41E082025-11-06
03664539004266NAMICRO MACRO ELECTRODEMM08-12L41F082025-11-06
03664539004273NAMICRO MACRO ELECTRODEMM08-12L41G082025-11-06
03664539004280NAMICRO MACRO ELECTRODEMM08-12L41H082025-11-06
03664539004297NAMICRO MACRO ELECTRODEMM08-12L41I082025-11-06
03664539004303NAMICRO MACRO ELECTRODEMM08-12L41J082025-11-06
03664539004310NAMICRO MACRO ELECTRODEMM08-12L41K082025-11-06
03664539004327NAMICRO MACRO ELECTRODEMM08-12L41L082025-11-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850011306338ATLAS Stim Headbox - TouchproofNEURALYNX, INC.GYC2025-06-11
00850011306345ATLAS Stim Headbox - High DensityNEURALYNX, INC.GYC2025-06-11
00850011306703ATLAS Stim Headbox SoftwareNEURALYNX, INC.GYC2025-06-11
00850011306710Fiber Optic Connector 2mNEURALYNX, INC.GYC2025-06-11
00850011306727Fiber Optic Connector 7mNEURALYNX, INC.GYC2025-06-11
00850011306901ATLAS Headbox Interface Cable - TouchproofNEURALYNX, INC.GYC2025-06-11
00850011306918ATLAS Headbox Interface Cable - NKNEURALYNX, INC.GYC2025-06-11
00850011306925ATLAS Headbox Interface Cable - High DensityNEURALYNX, INC.GYC2025-06-11
00867718000285ATLAS Stim Headbox - NKNEURALYNX, INC.GYC2025-06-11
00848530106249Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-06-03
10848530106246Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-06-03
00848530093693Suction KitSUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-05-19
00650551005445CORTAC®PMT CORPORATIONGYC2025-04-25
00650551005452CORTAC®PMT CORPORATIONGYC2025-04-25
00650551005469CORTAC®PMT CORPORATIONGYC2025-04-25
00650551005476CORTAC®PMT CORPORATIONGYC2025-04-25
00650551000884CORTAC®PMT CORPORATIONGYC2025-03-17
00650551002178CORTAC®PMT CORPORATIONGYC2025-03-17
00650551002840CORTAC®PMT CORPORATIONGYC2025-03-17
00650551002918CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003052CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003069CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003144CORTAC®PMT CORPORATIONGYC2025-03-17