FDA.reportPublic FDA data

sEEG DEPTHALON

Primary DI
00650551147404
Brand
sEEG DEPTHALON
Company
PMT CORPORATION
Model
2102-16-172
Device description
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
Published
2020-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GLZAntigens, If, Toxoplasma Gondii

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GLZAntigens, If, Toxoplasma GondiiMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650551147404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551147404006505511474046505511474040650551147404

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
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10650551093616NEW BEGINNINGS® GEL SHEETING3505-12025-03-19
10650551093623NEW BEGINNINGS® GELSHAPES®3505-102025-03-19
10650551093630NEW BEGINNINGS® GELSHAPES®3505-112025-03-19
10650551093647NEW BEGINNINGS® GELSHAPES®3505-122025-03-19
10650551093654NEW BEGINNINGS® GELSHAPES®3505-22025-03-19
10650551093661NEW BEGINNINGS® GELSHAPES®3505-32025-03-19
10650551093678NEW BEGINNINGS® GELSHAPES®3505-42025-03-19
10650551093685NEW BEGINNINGS® GELSHAPES®3505-52025-03-19
10650551093692NEW BEGINNINGS® GELSHAPES®3505-82025-03-19
20650551093613NEW BEGINNINGS® GEL SHEETING3505-1-62025-03-19
20650551093620NEW BEGINNINGS® GELSHAPES®3505-10-62025-03-19
00650551006978PMT® SUCTION INSTRUMENTS9002-07-100-ST2026-07-20
00650551006992CORTAC®2110-08-1452026-07-20
00650551006794ILSO™1515-08SF2026-07-18
00650551006800ILSO™1515-08MF2026-07-17
00650551006817ILSO™1515-08LF2026-07-17
00650551006824ILSO™1515-08XF2026-07-17
00650551006831ILSO™1515-08SM2026-07-17
00650551006848ILSO™1515-08MM2026-07-17
00650551006855ILSO™1515-08LM2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5229020101Toxo IgG IFA 120 TestHemagen Diagnostics, Inc.GLZ2023-10-05
G5229020201Toxo IgG IFA 204 TestHemagen Diagnostics, Inc.GLZ2023-10-05
G5229020211Toxo IgG IFA Slide Only KitHemagen Diagnostics, Inc.GLZ2023-10-05
00613745010052ImmunoFA 10x PBSGenBioGLZ2016-09-24
00613745010069ImmunoFA 10x PBSGenBioGLZ2016-09-24
00613745012001ImmunoFA Toxoplasma IgGGenBioGLZ2016-09-24
00613745012018ImmunoFA Toxoplasma SlidesGenBioGLZ2016-09-24
00613745012025ImmunoFA Toxoplasma IgG ConjugateGenBioGLZ2016-09-24
00613745012032ImmunoFA Toxoplasma IgG Negative ControlGenBioGLZ2016-09-24
00613745012049ImmunoFA Toxoplasma IgG Low ControlGenBioGLZ2016-09-24
00613745012056ImmunoFA Toxoplasma IgG High ControlGenBioGLZ2016-09-24
00613745012070ImmunoFA Toxoplasma SlidesGenBioGLZ2016-09-24
00613745013008ImmunoFA Toxoplasma IgMGenBioGLZ2016-09-24
00613745013091ImmunoFA Toxoplasma IgM ConjugateGenBioGLZ2016-09-24
00613745013411ImmunoFA Toxoplasma IgM Positive ControlGenBioGLZ2016-09-24