FDA.reportPublic FDA data

NA

Primary DI
03664539003726
Brand
NA
Company
DIXI MEDICAL
Model
ANCHOR BOLT
Catalog number
ACS-040SMS-10
Device description
"SET OF 10 ANCHOR BOLTS, LENGTH 40MM, LENGTH OF THE SELF-TAPPING THREAD 5MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
Published
2022-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K170959000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170959000DIXI Medical Microdeep Depth ElectrodeDixi Medical2017-11-24GZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664539003672PrimaryGS10
03664539003726Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664539003672036645390036723664539003672
03664539003726036645390037263664539003726

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
268009609
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841823111029Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-06-03
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