FDA.reportPublic FDA data

DEPTHALON

Primary DI
00650551000099
Brand
DEPTHALON
Company
PMT CORPORATION
Model
2104-07-57-009
Device description
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 46.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
Published
2021-06-29
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

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
00650551000099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551000099006505510000996505510000990650551000099

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039576871
Device count
1
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00650551006572DEPTHALON®2102-06-005-NS2026-05-26
00650551006589DEPTHALON®2102-06-0052026-05-26
00650551005445CORTAC®2110-06-0052110-06-0052025-04-25
00650551005452CORTAC®2110-08-0062025-04-25
00650551005469CORTAC®2110TX-16-0082025-04-25
00650551005476CORTAC®2110-32-0052025-04-25
00650551005391INTEGRA®3610ES-72-2I-ST2025-03-26
00650551002086PMT® SUCTION INSTRUMENTS9001-06-2252025-03-19
00650551002093PMT® SUCTION INSTRUMENTS9002-08-2252025-03-19
00650551002154INTEGRA®3611-204-2I-ST2025-03-19
00650551002161INTEGRA®3612-04-I-1T2025-03-19
00650551002772INTEGRA®3610-76-2I-ST2025-03-19
00650551002833INTEGRA®3612-06R-IR-ST2025-03-19
00650551002932ALLURA®3321-214-T2025-03-19
00650551002963INTEGRA®3612-61A-IR-ST72025-03-19
00650551003083INTEGRA®3610-23-32025-03-19
00650551003090INTEGRA®3611-674-32025-03-19
00650551003168INTEGRA®3611ES-12-IR-ST2025-03-19
00650551003175INTEGRA®3611ES-13-IR-ST2025-03-19
00650551003182INTEGRA®3612ES-04R-IR-ST2025-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006572DEPTHALON®PMT CORPORATIONGZL2026-05-26
00650551006589DEPTHALON®PMT CORPORATIONGZL2026-05-26
07290114064965HaGuide SoftwareALPHA OMEGA ENGINEERING CO. LTD.GZL2026-03-13
10873263009618microTargeting™ ElectrodeFHC, INC.GZL2026-03-12
00873263009628microTargeting™ ElectrodeFHC, INC.GZL2026-03-12
00841823110848Ad-Tech Macro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-02-23
00841823110855Ad-Tech Macro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-02-23
00841823110862Ad-Tech Macro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-02-23
00841823110879Ad-Tech Macro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-02-23
00841823110886Ad-Tech Macro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-02-23
00841823110893Ad-Tech Macro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-02-23
00841823110909Ad-Tech Macro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-02-23
00841823110916Ad-Tech Macro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-02-23
00841823110923Ad-Tech Macro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-02-23
03664539004365NADIXI MEDICALGZL2026-01-14
03664539004372NADIXI MEDICALGZL2026-01-14
00873263009499microTargeting™ ElectrodeFHC, INC.GZL2025-12-02
00841823108586Macro-Micro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2025-06-13
00841823108593Macro-Micro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2025-06-13
00841823109811Silicone Cap for LSB Anchor BoltAd-Tech Medical Instrument CorporationGZL2025-06-06
10873263009427microTargeting™ ElectrodeFHC, INC.GZL2025-05-21
00873263009413microTargeting™ ElectrodeFHC, INC.GZL2025-05-21
00873263008904microTargeting™ Single Procedure KitFHC, INC.GZL2025-04-30
00873263009031microTargeting™ Electrode CableFHC, INC.GZL2025-04-30
00873263008782microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
00873263008799microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
00873263008805microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
00873263008812microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
00873263008829microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
00873263008836microTargeting™ ElectrodeFHC, INC.GZL2025-04-30