FDA.reportPublic FDA data

NA

Primary DI
03664539000657
Brand
NA
Company
DIXI MEDICAL
Model
ANCHOR BOLT
Catalog number
ACS-020SMS-10
Device description
SET OF 10 ANCHOR BOLTS, LENGTH 20MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
Published
2017-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
03664539000657PrimaryGS10
03664539003276Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664539000657036645390006573664539000657
03664539003276036645390032763664539003276

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
Length0

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
false
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
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
03664539003610NACONNECTION CABLECBL-09/1502022-07-06
03664539003627NACONNECTION CABLECBL-09/1802022-07-06
03664539003634NACONNECTION CABLECBL-09/3002022-07-06
03664539003535NADRILL AND STOPKIP-ACS-515B2022-04-04
03664539000015NAMICRODEEP DEPTH ELECTRODED08-05AM2017-12-14
03664539000039NAMICRODEEP DEPTH ELECTRODED08-08AM2017-12-14
03664539000053NAMICRODEEP DEPTH ELECTRODED08-10AM2017-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006749DEPTHALON®PMT CORPORATIONGZL2026-06-09
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
10873263009496microTargeting™ ElectrodeFHC, INC.GZL2025-12-02
00841823110831Spencer Probe Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2025-11-07
10873263009410microTargeting™ 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
10873263009205microTargeting™ ElectrodeFHC, INC.GZL2024-04-12
03664539003900NADIXI MEDICALGZL2024-04-03
03664539003917NADIXI MEDICALGZL2024-04-03