FDA.reportPublic FDA data

DEPTHALON®

Primary DI
00650551096023
Brand
DEPTHALON®
Company
PMT CORPORATION
Model
2104-12-10-001-NS
Catalog number
2104-12-10-001-NS
Device description
MICROWIRE DEPTHALON ELECTRODE, 10 MICROWIRE CONTACTS, INLINE TAILS WITH 10CM LEADS
Published
2017-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00650551096023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551096023006505510960236505510960230650551096023

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
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature58 Degrees Fahrenheit78 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
800-626-5463intl@pmtcorp.com
800-626-5463info@pmtcorp.com

Regulatory Flags#

DUNS number
039576871
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

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
00650551005537DEPTHALON®2104-04-32-0012026-05-18
00650551005865MICROMAT®3105-M-B-122026-05-18
00650551005872MICROMAT®3105-M-Y-122026-05-18
00650551006022INTEGRA3610-76-ST2026-05-18
00650551006039INTEGRA3610-76-2-ST2026-05-18
00650551006046INTEGRA3611-690-2-ST2026-05-18
00650551006060INTEGRA3610-636-3-ST2026-05-18
00650551006077INTEGRA3611-230-2-ST2026-05-18
00650551006084INTEGRA3614-42-2-ST2026-05-18
00650551006091INTERCONNECTION CABLE2127-12-01-087-QDC2026-05-18
00650551006114CORTAC®2110-64-1692026-05-18
00650551006138DEPTHALON®2102-02-1912026-05-18
00650551006145INTERCONNECTION CABLE2127-16-04-Y92026-05-18
00650551006176INTEGRA3614-14-2-IR2026-05-18
00650551006220INTERCONNECTION CABLE2120-10-0102026-05-18
00650551006237INTEGRA3611-691-IR-ST2026-05-18
00650551006459INTERCONNECTION CABLE2120-16-01-0112026-05-18
00650551006480INTERCONNECTION CABLE2127-16-04-Y10-NS2026-05-18

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