FDA.reportPublic FDA data

SEEG-Tx®

Primary DI
03664539003931
Brand
SEEG-Tx®
Company
DIXI MEDICAL
Model
SEEG-Tx® System
Catalog number
STX - SYS - 001
Device description
System
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXDGenerator, Lesion, Radiofrequency
GXIProbe, Radiofrequency Lesion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXDGenerator, Lesion, RadiofrequencyNeurology2
GXIProbe, Radiofrequency LesionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260337000SEEG-Tx® System (STX-SYS-001)Dixi Medical2026-10-29GXD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664539003931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664539003931036645390039313664539003931

Contacts#

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

Regulatory Flags#

DUNS number
268009609
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664539003948SEEG-Tx®SEEG-Tx® GeneratorSTX - GEN – 0012026-11-03
03664539003955SEEG-Tx®SEEG-Tx® Interface boxSTX - INTB - 0012026-11-03
03664539003962SEEG-Tx®SEEG-Tx® Interface cableSTX - INTC - 0012026-11-03
03664539003986SEEG-Tx®SEEG-Tx® SimulatorSTX - ACC - 0202026-11-03
03664539003993SEEG-Tx®SEEG-Tx® Silicone rubberSTX - ACC – 0302026-11-03
03664539004006SEEG-Tx®SEEG-Tx® Equipotential cableSTX - ACC – 0402026-11-03
03664539004013SEEG-Tx®SEEG-Tx® Power cord USSTX - ACC – 0502026-11-03
03664539003405NAWIRE GUIDEACS-SG1S-52022-01-01
03664539003641NAANCHOR BOLTACS-125SMS-102022-10-10
03664539003658NAANCHOR BOLTACS-130SMS-102022-10-10
03664539003665NAANCHOR BOLTACS-135SMS-102022-10-10
03664539003672NAANCHOR BOLTACS-040SMS-102022-10-10
03664539003689NAANCHOR BOLTACS-140SMS-102022-10-10
03664539003900NAINSTRUMENT GUIDEACS-789/82R2024-04-03
03664539003917NAINSTRUMENT GUIDEACS-789/120R2024-04-03
03664539003559NACONNECTION CABLECBL-06/1202022-07-06
03664539003566NACONNECTION CABLECBL-06/1502022-07-06
03664539003573NACONNECTION CABLECBL-06/1802022-07-06
03664539003580NACONNECTION CABLECBL-06/3002022-07-06
03664539003603NACONNECTION CABLECBL-09/1202022-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03664539003948SEEG-Tx®DIXI MEDICALGXD2026-11-03
03664539003948SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539003955SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539003955SEEG-Tx®DIXI MEDICALGXD2026-11-03
03664539003962SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539003962SEEG-Tx®DIXI MEDICALGXD2026-11-03
03664539003986SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539003986SEEG-Tx®DIXI MEDICALGXD2026-11-03
03664539003993SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539003993SEEG-Tx®DIXI MEDICALGXD2026-11-03
03664539004006SEEG-Tx®DIXI MEDICALGXD2026-11-03
03664539004006SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539004013SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539004013SEEG-Tx®DIXI MEDICALGXD2026-11-03
05060224333341EpimedMINTA MEDICAL LIMITEDGXI2026-10-07
05060224334607EpimedMINTA MEDICAL LIMITEDGXI2026-10-07
04048223070291RGNPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070321RGNPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070727RFTLPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070758RFTLPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070772RFTLPajunk GmbH MedizintechnologieGXI2026-06-10
04048223084939ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085257ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085264ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085387ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085394ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085424ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085431ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085448ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085455ChibaPajunk GmbH MedizintechnologieGXI2026-06-10