FDA.reportPublic FDA data

CORTAC

Primary DI
00650551150411
Brand
CORTAC
Company
PMT CORPORATION
Model
2111-32-132
Device description
STAINLESS STEEL GRID ELECTRODE, 32 MACRO CONTACTS, 4X8, IOM CONNECTOR, 1 EXIT, 2 LEAD, 2 TAIL
Published
2020-05-18
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
GYCElectrode, Cortical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYCElectrode, CorticalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K845035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K845035000ELECTRODE FOR NEUROLOGICAL SURGERY 2111Progress Mankind Technology1985-07-30GYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650551150411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551150411006505511504116505511504110650551150411

GMDN Terms#

Term, Definition table
TermDefinition
Cortical electrodeA sterile, invasive, electrical conductor that is temporarily placed (< 30 days) on 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 series of discs mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The implanted device, also known as a subdural electrode, is connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039576871
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00650551006862ILSO™1515-08XM2026-07-17
00650551006879ITLSO™1535-08SF2026-07-17
00650551006886ITLSO™1535-08MF2026-07-17
00650551006893ITLSO™1535-08LF2026-07-17
00650551006909ITLSO™1535-08XF2026-07-17
00650551006916ITLSO™1535-08SM2026-07-17
00650551006923ITLSO™1535-08MM2026-07-17
00650551006930ITLSO™1535-08LM2026-07-17
00650551006947ITLSO™1535-08XM2026-07-17
00650551006954ILSO™1515-08CUSTOM2026-07-17
00650551006961ITLSO™1535-08CUSTOM2026-07-17
00650551006787PMT CORPORATION - STEREOTACTIC2103-15-402026-07-07
00650551006756CORTAC®2110-08-0292026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006756CORTAC®PMT CORPORATIONGYC2026-06-25
00650551006633CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006640CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006657CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006664CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006671CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006688CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006695CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006114CORTAC®PMT CORPORATIONGYC2026-05-18
00650551005858CORTACPMT CORPORATIONGYC2026-05-15
00650551005902CORTACPMT CORPORATIONGYC2026-05-15
00650551005964CORTAC®PMT CORPORATIONGYC2026-05-15
00840067103029ZenithCADWELL INDUSTRIES, INC.GYC2025-12-31
00848530106195Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-07-02
10848530106192Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-07-02
00850011306338ATLAS Stim Headbox - TouchproofNEURALYNX, INC.GYC2025-06-11
00850011306345ATLAS Stim Headbox - High DensityNEURALYNX, INC.GYC2025-06-11
00850011306703ATLAS Stim Headbox SoftwareNEURALYNX, INC.GYC2025-06-11
00850011306710Fiber Optic Connector 2mNEURALYNX, INC.GYC2025-06-11
00850011306727Fiber Optic Connector 7mNEURALYNX, INC.GYC2025-06-11
00850011306901ATLAS Headbox Interface Cable - TouchproofNEURALYNX, INC.GYC2025-06-11
00850011306918ATLAS Headbox Interface Cable - NKNEURALYNX, INC.GYC2025-06-11
00850011306925ATLAS Headbox Interface Cable - High DensityNEURALYNX, INC.GYC2025-06-11
00867718000285ATLAS Stim Headbox - NKNEURALYNX, INC.GYC2025-06-11
00848530106249Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-06-03
10848530106246Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-06-03
00848530093693Suction KitSUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-05-19
00650551005445CORTAC®PMT CORPORATIONGYC2025-04-25
00650551005452CORTAC®PMT CORPORATIONGYC2025-04-25
00650551005469CORTAC®PMT CORPORATIONGYC2025-04-25