FDA.reportPublic FDA data

NA

Primary DI
03664539004242
Brand
NA
Company
DIXI MEDICAL
Model
MICRO MACRO ELECTRODE
Catalog number
MM08-12L41D08
Device description
SEEG DEPTH ELECTRODE, 12 MACRO AND 8 MICRO-CONTACTS, EXPLORATION LENGTH 40.5MM, Ø 0.8MM
Published
2025-11-06
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
GZLElectrode, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202087000DIXI Medical Microdeep Micro-Macro Depth ElectrodesDixi Medical2021-11-18GZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664539004242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664539004242036645390042423664539004242

GMDN Terms#

Term, Definition table
TermDefinition
Depth electrodeAn electrical conductor intended to be temporarily placed (< 30 days) beneath 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 fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.

Device Sizes#

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

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
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
03664539004334NAMICRO MACRO ELECTRODEMM08-12L41M082025-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551005537DEPTHALON®PMT CORPORATIONGZL2026-05-18
00650551006138DEPTHALON®PMT CORPORATIONGZL2026-05-18
00650551005544DEPTHALON®PMT CORPORATIONGZL2026-05-15
00650551005919DEPTHALON®PMT CORPORATIONGZL2026-05-15
00650551005926DEPTHALON®PMT CORPORATIONGZL2026-05-15
00841823108814Anchor Bolt Kit, LSB StyleAd-Tech Medical Instrument CorporationGZL2026-04-08
10873263009625microTargeting™ ElectrodeFHC, INC.GZL2026-03-12
00873263009611microTargeting™ ElectrodeFHC, INC.GZL2026-03-12
10873263009496microTargeting™ ElectrodeFHC, INC.GZL2025-12-02
00841823110831Spencer Probe Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2025-11-07
10873263009410microTargeting™ ElectrodeFHC, INC.GZL2025-05-21
00873263009420microTargeting™ ElectrodeFHC, INC.GZL2025-05-21
10873263008789microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008796microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008802microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008819microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008826microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008833microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008840microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008857microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008871microTargeting™ Electrode and Insertion Tube KitFHC, INC.GZL2025-04-30
10873263008888microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008918microTargeting™ Electrode and Insertion Tube KitFHC, INC.GZL2025-04-30
00856895008634OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGZL2024-12-02
00856895008641OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGZL2024-12-02
00856895008658OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGZL2024-12-02
10873263009250microTargeting™ ElectrodeFHC, INC.GZL2024-09-02
00873263009239microTargeting™ ElectrodeFHC, INC.GZL2024-09-02
00873263009246microTargeting™ ElectrodeFHC, INC.GZL2024-09-02
10873263009205microTargeting™ ElectrodeFHC, INC.GZL2024-04-12