FDA.reportPublic FDA data

Micromed

Primary DI
08033928120828
Brand
Micromed
Company
MICROMED SPA
Model
SD LTM STIM
Device description
The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).
Published
2018-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K180761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180761000SD LTM STIM Cortical StimulatorMicromed S.P.A.2018-06-18GYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033928120828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033928120828080339281208288033928120828

GMDN Terms#

Term, Definition table
TermDefinition
Somatosensory electrical stimulation systemAn assembly of devices used to apply precisely timed and repeatable electrical stimuli to the peripheral nerves, typically for evoked potential and other research procedures (e.g., functional mapping in epilepsy). It is usually a multichannel external stimulation system, consisting of external surface electrodes or invasive (i.e., needle) electrodes, and a pulse generator. It may be used as a component of more complex devices such as somatosensory evoked-potential recording systems.

Regulatory Flags#

DUNS number
856998166
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033928120910micromedBRAIN QUICK2018-03-21
08033928121184MicromedLED PHOTIC2021-10-25
08033928121207MicromedLED PHOTIC POWER2021-10-25
08033928120880micromedSystemPlus EVOLUTION2018-03-21
08033928120958MicromedBRAIN QUICK SOFTWARE2018-05-21
08033928120736micromedSD LTM 32 EXPRESS2018-03-21
08033928120743micromedBRAIN SPY PLUS2018-03-21
08033928120750micromedSD LTM 64 EXPRESS2018-03-21
08033928120798micromedMORPHEUS2018-03-21
08033928120897MicromedSD LTM 64 PLUS2018-05-21
08033928120903MicromedSD LTM 32 PLUS2018-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00650551005476CORTAC®PMT CORPORATIONGYC2025-04-25
00650551000884CORTAC®PMT CORPORATIONGYC2025-03-17
00650551002178CORTAC®PMT CORPORATIONGYC2025-03-17
00650551002840CORTAC®PMT CORPORATIONGYC2025-03-17
00650551002918CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003052CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003069CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003144CORTAC®PMT CORPORATIONGYC2025-03-17