FDA.reportPublic FDA data

Spencer Probe Depth Electrode

Primary DI
00841823104229
Brand
Spencer Probe Depth Electrode
Company
Ad-Tech Medical Instrument Corporation
Model
LD12R-SP05X-000
Catalog number
LD12R-SP05X-000
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841823104229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841823104229008418231042298418231042290841823104229

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)776-1555sales@adtechmedical.com

Regulatory Flags#

DUNS number
174813410
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841823108814Anchor Bolt Kit, LSB StyleLSBK1-AX-05LSBK1-AX-052026-04-08
00841823108821Anchor Bolt Kit, LSB StyleLSBK1-BX-05LSBK1-BX-052023-08-28
00841823108838Anchor Bolt Kit, LSB StyleLSBK1-CX-04LSBK1-CX-042023-08-28
00841823108845Anchor Bolt Kit, LSB StyleLSBK1-CX-05LSBK1-CX-052023-08-28
00841823108852Anchor Bolt Kit, LSB StyleLSBK2-AX-04LSBK2-AX-042023-08-28
00841823108869Anchor Bolt Kit, LSB StyleLSBK2-BX-04LSBK2-BX-042023-08-28
00841823109521Anchor Bolt Kit, LSB StyleLSBK1-CX-06LSBK1-CX-062023-08-28
00841823109538Anchor Bolt Kit, LSB StyleLSBK1-BX-06LSBK1-BX-062023-08-28
00841823109545Anchor Bolt Kit, LSB StyleLSBK1-AX-06LSBK1-AX-062023-08-28
00841823101228Subdural ElectrodeDG20A-SP07X-UPBDG20A-SP07X-UPB2016-09-23
00841823101235Subdural ElectrodeDG20A-SP10X-G00DG20A-SP10X-G002016-09-23
00841823101242Subdural ElectrodeDG20A-SP10X-GE2DG20A-SP10X-GE22016-09-23
00841823101259Subdural ElectrodeDG20A-SP10X-T00DG20A-SP10X-T002016-09-23
00841823101266Subdural ElectrodeDG20A-SP10X-U00DG20A-SP10X-U002016-09-23
00841823101273Subdural ElectrodeDG20A-SP10X-UE2DG20A-SP10X-UE22016-09-23
00841823101280Subdural ElectrodeDG24A-SP10X-000DG24A-SP10X-0002016-09-23
00841823101297Subdural ElectrodeDG24A-SP10X-G00DG24A-SP10X-G002016-09-23
00841823101303Subdural ElectrodeDG32A-SP10X-U00DG32A-SP10X-U002016-09-23
00841823101310Subdural ElectrodeDG32A-SP10X-V00DG32A-SP10X-V002016-09-23
00841823101327Subdural ElectrodeDG48B-SP10X-G00DG48B-SP10X-G002016-09-23

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