FDA.report

DEPTHALON®

Primary DI
00650551096016
Brand
DEPTHALON®
Company
PMT CORPORATION
Model
2104-10-14-001-NS
Catalog number
2104-10-14-001-NS
Device description
MICROWIRE DEPTHALON ELECTRODE, 14 MICROWIRE CONTACTS, INLINE CONNECTOR WITH 10CM LEAD
Published
2017-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GZLElectrode, Depth

Product Code Classifications

CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00650551096016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551096016006505510960166505510960160650551096016

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature58 Degrees Fahrenheit78 Degrees Fahrenheit

Sterilization Methods

Method
Hydrogen Peroxide

Contacts

PhoneEmail
800-626-5463info@pmtcorp.com

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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

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 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